Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
SF Research Institute, Inc.
51 participants
Oct 26, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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
- 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.
Exclusion Criteria15
- 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 study result difficult
- 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
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Interventions
Shatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily.
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 (starch)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06716554