Trial Outcomes & Findings for Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin (NCT NCT02370121)

NCT ID: NCT02370121

Last Updated: 2019-06-18

Results Overview

The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2019-06-18

Participant Flow

Participant milestones

Measure	Placebo 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Overall Study STARTED	12	12
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Placebo 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

Baseline characteristics by cohort

Measure	Placebo n=12 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=12 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Total n=24 Participants Total of all reporting groups
Age, Continuous	41 years STANDARD_DEVIATION 4 • n=93 Participants	43 years STANDARD_DEVIATION 1 • n=4 Participants	42 years STANDARD_DEVIATION 4 • n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	10 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=93 Participants	12 Participants n=4 Participants	24 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Mexico	12 participants n=93 Participants	12 participants n=4 Participants	24 participants n=27 Participants
Body weight (BW)	78.8 kg STANDARD_DEVIATION 16.1 • n=93 Participants	81.3 kg STANDARD_DEVIATION 10.6 • n=4 Participants	80.2 kg STANDARD_DEVIATION 15.4 • n=27 Participants
Body mass index (BMI)	30.29 kg/m^2 STANDARD_DEVIATION 3.21 • n=93 Participants	31.24 kg/m^2 STANDARD_DEVIATION 2.55 • n=4 Participants	30.56 kg/m^2 STANDARD_DEVIATION 2.98 • n=27 Participants
Waist circumference (WC)	98 cm STANDARD_DEVIATION 14 • n=93 Participants	99 cm STANDARD_DEVIATION 10 • n=4 Participants	98 cm STANDARD_DEVIATION 14 • n=27 Participants
Systolic blood pressure (SBP)	123 mmHg STANDARD_DEVIATION 11 • n=93 Participants	121 mmHg STANDARD_DEVIATION 10 • n=4 Participants	122 mmHg STANDARD_DEVIATION 15 • n=27 Participants
Diastolic blood pressure (DBP)	81 mmHg STANDARD_DEVIATION 7 • n=93 Participants	79 mmHg STANDARD_DEVIATION 5 • n=4 Participants	81 mmHg STANDARD_DEVIATION 6 • n=27 Participants
Triglycerides (TGs)	2.91 mmol/L STANDARD_DEVIATION 0.93 • n=93 Participants	2.37 mmol/L STANDARD_DEVIATION 1.03 • n=4 Participants	2.69 mmol/L STANDARD_DEVIATION 0.90 • n=27 Participants
Total cholesterol (TC)	4.53 mmol/L STANDARD_DEVIATION 0.52 • n=93 Participants	4.60 mmol/L STANDARD_DEVIATION 1.06 • n=4 Participants	4.59 mmol/L STANDARD_DEVIATION 0.63 • n=27 Participants
high-density lipoprotein cholesterol (HDL-C)	1.00 mmol/L STANDARD_DEVIATION 0.23 • n=93 Participants	1.11 mmol/L STANDARD_DEVIATION 0.18 • n=4 Participants	1.04 mmol/L STANDARD_DEVIATION 0.22 • n=27 Participants
Low-density lipoprotein cholesterol (LDL-C)	2.12 mmol/L STANDARD_DEVIATION 0.59 • n=93 Participants	2.48 mmol/L STANDARD_DEVIATION 0.93 • n=4 Participants	2.15 mmol/L STANDARD_DEVIATION 0.52 • n=27 Participants
Very-low density lipoprotein (VLDL)	0.54 mmol/L STANDARD_DEVIATION 0.17 • n=93 Participants	0.45 mmol/L STANDARD_DEVIATION 0.15 • n=4 Participants	0.49 mmol/L STANDARD_DEVIATION 0.16 • n=27 Participants
Fasting plasma glucose (FPG)	4.97 mmol/L STANDARD_DEVIATION 0.44 • n=93 Participants	5.22 mmol/L STANDARD_DEVIATION 0.72 • n=4 Participants	5.09 mmol/L STANDARD_DEVIATION 0.58 • n=27 Participants
2-hour postload plasma glucose (2-h PG)	7.72 mmol/L STANDARD_DEVIATION 1.78 • n=93 Participants	7.61 mmol/L STANDARD_DEVIATION 1.89 • n=4 Participants	7.67 mmol/L STANDARD_DEVIATION 184 • n=27 Participants
Area under the curve of glucose (AUCG)	972 mmol/L/min STANDARD_DEVIATION 154 • n=93 Participants	979 mmol/L/min STANDARD_DEVIATION 182 • n=4 Participants	976 mmol/L/min STANDARD_DEVIATION 168 • n=27 Participants
Area under the curve of insulin (AUCI)	64314 pmol/L/min STANDARD_DEVIATION 34914 • n=93 Participants	61626 pmol/L/min STANDARD_DEVIATION 29700 • n=4 Participants	62970 pmol/L/min STANDARD_DEVIATION 32307 • n=27 Participants
Total insulin secretion	0.61 unitless STANDARD_DEVIATION 0.33 • n=93 Participants	0.57 unitless STANDARD_DEVIATION 0.24 • n=4 Participants	0.59 unitless STANDARD_DEVIATION 0.57 • n=27 Participants
First phase of insulin secretion	1403 unitless STANDARD_DEVIATION 682 • n=93 Participants	1458 unitless STANDARD_DEVIATION 510 • n=4 Participants	1431 unitless STANDARD_DEVIATION 596 • n=27 Participants
Insulin sensitivity	3.3 unitless STANDARD_DEVIATION 1.9 • n=93 Participants	3.8 unitless STANDARD_DEVIATION 1.1 • n=4 Participants	3.6 unitless STANDARD_DEVIATION 1.5 • n=27 Participants

PRIMARY outcome

Timeframe: Week 12

Population: All participants, including those who dropped out before the end were taken into account for statical analysis (intention to treat).

The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Waist Circumference (WC)	101 cm Standard Deviation 15	96 cm Standard Deviation 7

PRIMARY outcome

Timeframe: week 12

The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Triglycerides (TGs)	2.79 mmol/L Standard Deviation 0.59	1.70 mmol/L Standard Deviation 0.75

PRIMARY outcome

Timeframe: Week 12

The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L.

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
High-density Lipoprotein Cholesterol (HDL-C)	1.03 mmol/L Standard Deviation 0.25	1.08 mmol/L Standard Deviation 0.31

PRIMARY outcome

Timeframe: week 12

The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Fasting Plasma Glucose (FPG)	5.00 mmol/L Standard Deviation 0.61	4.83 mmol/L Standard Deviation 0.72

PRIMARY outcome

Timeframe: week 12

The SBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg.

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Systolic Blood Pressure (SBP)	122 mmHg Standard Deviation 13	121 mmHg Standard Deviation 11

PRIMARY outcome

Timeframe: week 12

The DBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg.

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Diastolic Blood Pressure (DBP)	83 mmHg Standard Deviation 7	78 mmHg Standard Deviation 8

PRIMARY outcome

Timeframe: Week 12

The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Total Insulin Secretion	0.95 unitless Standard Deviation 0.66	0.59 unitless Standard Deviation 0.25

PRIMARY outcome

Timeframe: week 12

The first phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0').

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
First Phase of Insulin Secretion	1805 unitless Standard Deviation 721	1366 unitless Standard Deviation 472

PRIMARY outcome

Timeframe: week 12

The insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)].

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Insulin Sensitivity	2.5 unitless Standard Deviation 1.4	4.1 unitless Standard Deviation 2.1

SECONDARY outcome

Timeframe: week 12

The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Body Weight (BW)	80.3 kg Standard Deviation 18.2	77.9 kg Standard Deviation 8.4

SECONDARY outcome

Timeframe: week 12

The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Body Mass Index (BMI)	30.70 kg/m^2 Standard Deviation 3.75	30.43 kg/m^2 Standard Deviation 2.23

SECONDARY outcome

Timeframe: week 12

The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Total Cholesterol (TC)	5.04 mmol/L Standard Deviation 0.62	4.55 mmol/L Standard Deviation 0.98

SECONDARY outcome

Timeframe: Week 12

The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L.

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Low-density Lipoprotein Cholesterol (LDL-C)	2.77 mmol/L Standard Deviation 0.54	2.69 mmol/L Standard Deviation 0.59

SECONDARY outcome

Timeframe: week 12

The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5. The value was expressed on mmol/L.

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Very-low Density Lipoprotein (VLDL)	0.56 mmol/L Standard Deviation 0.12	0.35 mmol/L Standard Deviation 0.15

SECONDARY outcome

Timeframe: week 12

The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
2-hour Postload Plasma Glucose (2-h PG)	6.83 mmol/L Standard Deviation 2.00	7.22 mmol/L Standard Deviation 3.05

SECONDARY outcome

Timeframe: week 12

The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min.

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Area Under the Curve of Glucose (AUCG)	965 mmol/L/min Standard Deviation 235	914 mmol/L/min Standard Deviation 267

SECONDARY outcome

Timeframe: week 12

The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min.

Outcome measures

Measure	Placebo n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=11 Participants 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Area Under the Curve of Insulin (AUCI)	90816 pmol/L/min Standard Deviation 45336	60468 pmol/L/min Standard Deviation 37290

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Gymnema Sylvestre

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=12 participants at risk 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.	Gymnema Sylvestre n=12 participants at risk 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Nervous system disorders headache	16.7% 2/12 • Number of events 2 • Adverse events were collected throughout the 90 days of the study.	8.3% 1/12 • Number of events 1 • Adverse events were collected throughout the 90 days of the study.
Gastrointestinal disorders Diarrhea	8.3% 1/12 • Number of events 1 • Adverse events were collected throughout the 90 days of the study.	16.7% 2/12 • Number of events 2 • Adverse events were collected throughout the 90 days of the study.
Gastrointestinal disorders Abdominal distension	8.3% 1/12 • Number of events 1 • Adverse events were collected throughout the 90 days of the study.	8.3% 1/12 • Number of events 1 • Adverse events were collected throughout the 90 days of the study.
Gastrointestinal disorders Pyrosis	0.00% 0/12 • Adverse events were collected throughout the 90 days of the study.	16.7% 2/12 • Number of events 2 • Adverse events were collected throughout the 90 days of the study.
Metabolism and nutrition disorders Polydipsia	0.00% 0/12 • Adverse events were collected throughout the 90 days of the study.	16.7% 2/12 • Number of events 2 • Adverse events were collected throughout the 90 days of the study.

Additional Information

Dra. Esperanza Martínez Abundis

Institute of Experimental and Clinical Therapeutics

Phone: +52-33-10-58-52-00

Email: esperanzamartnezabundi@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place