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

What this trial studies

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.

Conditions in scope

• Menopause
• Hot Flashes
• Mood

Interventions

• Shatavari extract (Dietary Supplement) — Shatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily.
• Shatavari + Ashwagandha extract (Dietary Supplement) — 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 (Dietary Supplement) — Placebo (starch)

Who can join

Women only · Ages 45 Years to 55 Years · Accepts healthy volunteers.

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2024-10-26
• Primary completion: 2024-12-26
• Last update posted: 2024-12-04
• First posted: 2024-12-04

Sponsor & contact

Lead sponsor: SF Research Institute, Inc. (Network)

Collaborators: Ixoreal Biomed Inc.

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Menopause Rating Scale (MRS) (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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.