To Evaluate add-on Effect of Nisha-Amalaki Tablets Along With Insulin on Glycemic Control in Type 1 Diabetes Patients (RCTNA)
NCT ID: NCT06487598
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
70 participants
INTERVENTIONAL
2024-07-01
2025-07-31
Brief Summary
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Significant advancements are being made in the field of T1DM research, including stem cell therapy, islet cell transplantation, and immunotherapies, which hold promise for the future. However, so far, there is no known permanent cure for T1DM. Thus, treatment of T1DM aims at maintaining normal blood sugar levels through regular monitoring, insulin therapy, diet, and exercise.
Dietary constituents play an important role in the management of T1DM. Studies have shown that the fruits of Phyllanthus emblica Linn, colloquially known as Indian gooseberry (amla), and/or some of its important constituents (including gallic acid, gallotanin, ellagic acid, and corilagin) possess anti-diabetic actions through their antioxidant and free-radical-scavenging properties. Amla has also been reported to prevent or reduce hyperglycemia, cardiac complications, diabetic nephropathy, neuropathy, cataract genesis, and protein wasting. However, clinical trial data with human subjects are limited and preliminary.
Numerous studies also report that turmeric (Curcuma longa) has antioxidant, anti-inflammatory, and anti-diabetic activities and can lower lipid levels. The hypoglycaemic effect of turmeric may be due to increased peripheral glucose utilization, decreased hepatic glucose synthesis, and/or increased insulin secretion.
In Ayurveda, the combination of turmeric (haridra) and amla (amalaki) is strongly recommended for Prameha (Diabetes mellitus).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Arm1-Only insulin treatment for type 1 Diabetes patients
Arm1:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient for 3 months.
inj insulin to one group
One group- only inj insulin for 3 months.
Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day
second group- Inj Insulin with Tab Nisha-Dhatri 500 mg twice a day
Arm2-Insulin with Nisha-Amalaki tablets
Arm2:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient with Tab Nisha-Amalaki Dhootpapeshwar GMP certified 500 mg twice a day for 3 months.
inj insulin to one group
One group- only inj insulin for 3 months.
Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day
second group- Inj Insulin with Tab Nisha-Dhatri 500 mg twice a day
Interventions
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inj insulin to one group
One group- only inj insulin for 3 months.
Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day
second group- Inj Insulin with Tab Nisha-Dhatri 500 mg twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
3. Parents provide consent and children providing assent for the study
Exclusion Criteria
2. Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
3. Parents provide consent and children providing assent for the study
10 Years
18 Years
ALL
No
Sponsors
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Hirabai Cowasji Jehangir Medical Research Institute
OTHER
Responsible Party
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Dr. Anuradha Khadilkar
Consultant Pediatrician and Deputy Director
Locations
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Hirabai Cowasji Jehangir Medical Research Institute
Pune, Maharashtra, India
Countries
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Other Identifiers
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JCDC/BHR/24/032
Identifier Type: -
Identifier Source: org_study_id
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