Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
NCT ID: NCT06716554
Last Updated: 2024-12-04
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
51 participants
INTERVENTIONAL
2024-10-26
2025-01-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In this study, a maximum of 51 patients will be enrolled and the goal is to complete the study with at least 45 patients.
After signing this consent form, participants will answer questions regarding their medical history, including any medications they are taking. Physical exams with vital signs (pulse, temperature, sitting blood pressure and respiratory rate) will be performed at both visits by a professional trained to perform this testing.
It may be a Nurse (RN or LPN), Phlebotomist, or Medical Doctor. In order to be qualified to participate this study at initial Visit (Baseline), BMI score range between 18-35 are required.
A blood sample will be required from subjects. Subject's right or left arm will be used as the blood draw site, requiring a 5mL sample. The blood will be analyzing Sr. Estradiol, FSH, LH, Testosterone levels. These blood draws will be administered by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist or Medical Doctor.
All eligible participants, will be given the required quantity of the study medication for self-administration, sufficient till the Visit 3- End of study visit, 8 weeks ± 4 Days. Participants will be randomized to either one of the three treatment arms.
Participants will be instructed to take one capsule of study medication to which they are randomized after breakfast, with ambient temperature water for 8 weeks at home. Participants will be asked to visit the site for Visit 2 (4 weeks ± 4 Days), Visit 3 (8 weeks ± 4 Days). Adverse events and concomitant medication will be recorded throughout the study. Participants will be asked to get used and unused study medications and their subject diaries in this visit. All the participants will be asked to continue their routine diet and physical activities during the whole study period.
The primary end point is the mean change in score for Menopause Rating Scale (MRS) from baseline. And the secondary end points are mean changes in scores for Perceived Stress Scale (PSS) questionnaire, Menopause Symptoms Treatment Questionnaire (MENQOL) scores, Profile of Mood States (POMS, abbreviated version) and mean changes in Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) levels from baseline.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Shatavari
One capsule of Shatavari 300 mg (contains Shatavari extract) once a day, orally with water.
Shatavari extract
Shatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily.
Shatavari + Ashwagandha
One capsule of Shatavari (300mg) + Ashwagandha (250mg) (contains Shatavari + Ashwagandha root extract) once a day, orally with water.
Shatavari + Ashwagandha extract
Shatavari is scientifically known as Asparagus racemosus along with Ashwagandha root extract scientifically known as Withania somnifera. One capsule containing Shatavari 300mg + Ashwagandha root extract 250mg should be taken once daily.
Placebo
One capsule of Placebo 300 mg (contains starch extract) once a day, orally with water.
Placebo
Placebo (starch)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Shatavari extract
Shatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily.
Shatavari + Ashwagandha extract
Shatavari is scientifically known as Asparagus racemosus along with Ashwagandha root extract scientifically known as Withania somnifera. One capsule containing Shatavari 300mg + Ashwagandha root extract 250mg should be taken once daily.
Placebo
Placebo (starch)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days
3. Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
4. Body mass index 18-35 kg/m2
5. Subject who has given written informed consent to participate in the study and understand the nature of the study
6. Able to read and write in English or any other vernacular language
7. No plan to commence new treatments over the study period.
8. Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
Exclusion Criteria
2. Participants who are on hormone replacement therapy (HRT) for more than 3 months.
3. Participants with Present active medical, surgical, and gynaecological problems.
4. Participants with a history of alcohol, tobacco dependence, or any substance abuse
5. Participants who had undergone bilateral ovariectomy
6. Participants with history of breast or cervical carcinoma
7. Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate.
8. Participants with Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult
9. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
10. Participants with evidence of uncooperative attitude, including poor compliance.
11. Participants with inability to attend follow-up visit
12. Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.
13. Patients with known hypersensitivity to Ashwagandha.
14. Patients who had participated in other clinical trials during the previous 3 months.
15. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol
45 Years
55 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ixoreal Biomed Inc.
UNKNOWN
SF Research Institute, Inc.
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SF Research Institute, Inc.
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
John Ademola
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHT-1076-2024-1
Identifier Type: -
Identifier Source: org_study_id