RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-26

Study Completion:2025-01-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06716554

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 55 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Menopausal women aged 45 to 65 years with intact uterus and ovaries. 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.	1. Participants taking any form of herbal extract in the last 3 months before study entry. 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

Inclusion Criteria

Exclusion Criteria

1. Menopausal women aged 45 to 65 years with intact uterus and ovaries.
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.

1. Participants taking any form of herbal extract in the last 3 months before study entry.
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

Contacts and Locations

Study Contact

Khaleeq Rehman

CONTACT

+1 (415) 690-9641

khaleeqr.sfinstitute@gmail.com

John Ademola

CONTACT

+1 (415) 845-4638

jademola@sfinstitute.com

Study Locations (Sites)

SF Research Institute, Inc.

San Francisco, California, 94127

United States

Collaborators and Investigators

Sponsor: SF Research Institute, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-26

Study Completion Date2025-01-20

Study Record Updates

Study Start Date2024-10-26

Study Completion Date2025-01-20

Terms related to this study

Additional Relevant MeSH Terms

Menopause
Hot Flashes
Mood