Shatavari Root Extract for Perimenopausal Symptoms

NCT07441109 | Not Yet Recruiting

• 1 other identifier: Ixo/2025/1341/SHT/Perime/GB/08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, placebo-controlled clinical study evaluates the efficacy and safety of a standardized Shatavari (Asparagus racemosus) root extract in women experiencing perimenopausal symptoms. Participants will receive either Shatavari root extract or a matched placebo for 12 weeks. Efficacy will be assessed using validated menopause-specific symptom, quality-of-life, stress, mood, and sleep questionnaires, along with physiological stress markers. Safety will be evaluated through laboratory assessments and adverse event monitoring.

Conditions

Perimenopause; Women Health

Keywords

Shatavari; Dietary Supplement

Outcome Measures

Primary Outcomes (1)

• Change in Menopause Rating Scale (MRS) Total Score

  The Menopause Rating Scale (MRS) is a validated 11-item questionnaire assessing the severity of menopausal symptoms across three domains: psychological, somato-vegetative, and urogenital. Each item is scored from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 44, with higher scores indicating more severe menopausal symptoms (worse outcome). This outcome measures the mean change from baseline in MRS total score, where a reduction in score indicates improvement in overall perimenopausal symptom burden.

  Baseline, Week 4, Week 8, Week 12

Secondary Outcomes (12)

• Change in Menopause-Specific Quality of Life (MENQOL) Scores

  Baseline, Week 4, Week 8, Week 12

• Change in Hot Flash-Related Daily Interference Scale (HFRDIS) Scores

  Baseline, Week 4, Week 8, Week 12

• Change in Perceived Stress Scale (PSS-10) Scores

  Baseline, Week 4, Week 8, Week 12

• Change in Pittsburgh Sleep Quality Index (PSQI) Scores

  Baseline, Week 4, Week 8, Week 12

• Change in Profile of Mood States (POMS) Scores

  Baseline, Week 4, Week 8, Week 12

Study Arms (2)

Shatavari Root Extract (SRI-81) 300 mg

EXPERIMENTAL

Participants will receive a standardized Shatavari (Asparagus racemosus) root extract capsule containing 300 mg, administered orally once daily after breakfast with water for 12 weeks.

Dietary Supplement: Shatavari (Asparagus racemosus) Root Extract

Placebo Capsule (Starch) 300 mg

PLACEBO COMPARATOR

Participants will receive an identical placebo capsule containing 300 mg of starch, administered orally once daily after breakfast with water for 12 weeks.

Other: Placebo Capsule

Interventions

Shatavari (Asparagus racemosus) Root Extract DIETARY_SUPPLEMENT

A standardized Shatavari root extract manufactured under cGMP conditions with an herb-to-extract ratio of 13:1 and standardized to contain ≥10% total Shatavarins. Participants will self-administer one capsule daily for 12 weeks.

Shatavari Root Extract (SRI-81) 300 mg

Placebo Capsule OTHER

An inert starch-filled capsule identical in appearance, color, and packaging to the active intervention, administered once daily for 12 weeks to maintain blinding.

Placebo Capsule (Starch) 300 mg

Eligibility Criteria

• Age: 40 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Menopausal women aged \>40 to 45 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 at least two of the menopausal symptoms, e.g., hot flashes, night sweats, mood swings, sleep disturbance, breast tenderness
• 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 si

You may not qualify 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 who are pregnant.
• 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 demonstrated inability to follow study protocols or attend follow-up visits, including poor compliance.
• Participants with demonstrated inability to follow study protocols or attend follow-up visit
• 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 who had participated in other clinical trials during the previous 3 months.

Sponsors & Collaborators

• SF Research Institute, Inc.: lead
• Ixoreal Biomed Private Limited: collaborator

Study Sites (1)

San Francisco Research Institute

San Francisco, California, 94132, United States

Location

Central Study Contacts

Dr. John Ademola

CONTACT

415-845-4638; jademola@sfinstitute.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: March 11, 2026
• Primary Completion: June 15, 2026
• Study Completion (Estimated): June 29, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)