Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study

Phase

N/A

Condition

Menopause

Treatment

Shatavari + Ashwagandha extract

Placebo

Shatavari extract

Clinical Study ID

NCT06716554

SHT-1076-2024-1

Ages 45-55
Female
Accepts Healthy Volunteers

Study Summary

This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari for the treatment of Menopausal symptoms in Women. Participants will be randomized to either one of the three treatment arms.Participants will then be asked to either take one capsule containing Shatavari or Shatavari + Ashwagandha or Placebo orally once daily in the morning after breakfast with a glass of water for 8 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. The primary objective is to compare the efficacy of shatavari for treatment of menopausal symptoms in women. The secondary objective is to compare the safety of shatavari for treatment of menopausal symptoms in women.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Menopausal women aged 45 to 65 years with intact uterus and ovaries.
Participants who complained of irregular menstrual cycle in the past 12 months, witha forward or postpone of a cycle more 7 days. At least 2 cycles were missing duringthe past 12 months, or reported menopause for at least 60 days
Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine,easy irritation, etc.
Body mass index 18-35 kg/m2
Subject who has given written informed consent to participate in the study andunderstand the nature of the study
Able to read and write in English or any other vernacular language
No plan to commence new treatments over the study period.
Must have the ability and willingness to sign an informed consent and to comply withall study procedures.

Exclusion

Exclusion Criteria:

Participants taking any form of herbal extract in the last 3 months before studyentry.
Participants who are on hormone replacement therapy (HRT) for more than 3 months.
Participants with Present active medical, surgical, and gynaecological problems.
Participants with a history of alcohol, tobacco dependence, or any substance abuse
Participants who had undergone bilateral ovariectomy
Participants with history of breast or cervical carcinoma
Participants who taking medication that affect bone metabolism, includingglucocorticoid, anticonvulsant, and methotrexate.
Participants with Clinically relevant cardiovascular, gastrointestinal, hepatic,neurologic, endocrine, haematologic or other major systemic diseases makingimplementation of the protocol or other interpretation of the study result difficult
Participants with mental condition rendering the subject unable to understand thenature, scope, and possible consequences of the study
Participants with evidence of uncooperative attitude, including poor compliance.
Participants with inability to attend follow-up visit
Participants with any other medical condition (for example uncontrolled infection)that may, in the opinion of the Investigator, interfere with the study objective.
Patients with known hypersensitivity to Ashwagandha.
Patients who had participated in other clinical trials during the previous 3 months.
Patients who have any clinical condition, according to the investigator who does notallow safe fulfilment of clinical trial protocol

Study Design

Shatavari + Ashwagandha extract

October 26, 2024

January 20, 2025

Study Description

To qualify for the study, participants must be menopausal women aged 45 to 65 years with intact uterus and ovaries. 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. Women with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.

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.

Connect with a study center

SF Research Institute, Inc.
San Francisco, California 94127
United States
Active - Recruiting

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