NCT06716554 · SF Research Institute, Inc.
Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
What this study is about
This is a Multi-center, Multi-national, forward-looking, randomly assigned, where neither patients nor doctors know which treatment is given, Placebo- Controlled three treatment group$1 study to evaluate the effectiveness and safety of Shatavari for the treatment of Menopausal symptoms in Women. Participants will be randomly assigned to either one of the three treatment treatment group$1.
View original scientific 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.
Interventions
DIETARY_SUPPLEMENT
Shatavari extract
Shatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily.
DIETARY_SUPPLEMENT
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.
DIETARY_SUPPLEMENT
Placebo
Placebo (starch)
Primary outcome measures
Menopause Rating Scale (MRS)
Time frame: MRS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).
The scale consisted of 11 items, ranging from no symptoms to very severe symptoms. The total score of the MRS ranges from 0 (asymptomatic) to 44 (highest degree of complaints). The minimal/maximal scores vary between the three dimensions, depending on the number of complaints allocated to the respective dimension of symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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, 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 criteria
- 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
Where
- San Francisco, California
Collaborators
Ixoreal Biomed Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 4, 2024 · Source of record for eligibility and locations