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Tests treatment safety and results for Menopause
Official title Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
ClinicalTrials.gov ID: NCT06716554
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 55, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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 and understand the nature of the study
You likely can't join if
- Participants taking any form of herbal extract in the last 3 months before study entry.
- 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
See the full eligibility 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, 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...
- 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 and understand 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 with all study procedures.
- Participants taking any form of herbal extract in the last 3 months before study entry.
- 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, including glucocorticoid, anticonvulsant, and methotrexate.
- 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...
- Participants with mental condition rendering the subject unable to understand the nature, 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 not allow safe fulfilment of clinical trial protocol
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.