Efficacy and Safety of Shatavari Root Extract for Premenstrual Syndrome in Women

NCT07441096 | Not Yet Recruiting

• 1 other identifier: Ixo/2025/1315/SHT/PMS/GB/02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Premenstrual syndrome (PMS) is a common condition that affects women of reproductive age and is associated with emotional, physical, and behavioral symptoms such as mood swings, irritability, stress, sleep problems, fatigue, and abdominal discomfort. These symptoms typically occur during the days leading up to menstruation and may interfere with daily activities and overall quality of life. This study is designed to evaluate the efficacy and safety of Shatavari (Asparagus racemosus) root extract compared with placebo in women with mild to moderate PMS. Eligible participants will be randomly assigned to receive either Shatavari root extract (300 mg) or an identical placebo capsule once daily for 12 weeks. The study will assess changes in PMS symptoms, stress levels, sleep quality, and quality of life using validated questionnaires, along with measurements of salivary cortisol. Safety will be evaluated through clinical laboratory tests and monitoring of adverse events throughout the study.

Conditions

Premenstrual Syndrome; Women Health

Keywords

PMS; Shatavari; Asparagus racemosus

Outcome Measures

Primary Outcomes (1)

• Change in Daily Record of Severity of Problems (DRSP) Total Score

  The Daily Record of Severity of Problems (DRSP) is a validated patient-reported questionnaire used to assess emotional, physical, and functional symptoms associated with premenstrual syndrome (PMS). The DRSP consists of 21 items scored daily from 1 (not at all) to 6 (extreme). The total score ranges from 21 to 126, with higher scores indicating greater symptom severity (worse outcome). DRSP scores will be recorded daily and averaged/summarized for each assessment visit. This outcome measures the mean change from baseline in DRSP total score, where a reduction in score indicates improvement in premenstrual symptom severity.

  Baseline, Week 4, Week 8, and Week 12

Secondary Outcomes (10)

• Change in Perceived Stress Scale (PSS) Score

  Baseline, Week 4, Week 8, and Week 12

• Change in Pittsburgh Sleep Quality Index (PSQI) Score

  Baseline, Week 4, Week 8, and Week 12

• Change in Women's Quality of Life Questionnaire (WOMQOL) Score

  Baseline, Week 4, Week 8, and Week 12

• Change in Bedtime Salivary Cortisol Level

  Baseline and Week 12

• Change in Cortisol Awakening Response (CAR)

  Baseline and Week 12

Study Arms (2)

Shatavari Root Extract

EXPERIMENTAL

Participants assigned to this arm will receive Shatavari (Asparagus racemosus) root extract capsules at a dose of 300 mg taken orally once daily for 12 weeks.

Dietary Supplement: Shatavari Root Extract

Placebo (Inactive capsule)

PLACEBO COMPARATOR

Participants assigned to this arm will receive an identical placebo capsule containing starch, taken orally once daily for 12 weeks.

Other: Placebo Capsule

Interventions

Shatavari Root Extract DIETARY_SUPPLEMENT

Shatavari (Asparagus racemosus) root extract is a standardized herbal dietary supplement formulated as an oral capsule. Each capsule contains 300 mg of Shatavari root extract standardized to total shatavarins. Participants will take one capsule orally once daily in the morning with water for a duration of 12 weeks.

Shatavari Root Extract

Placebo Capsule OTHER

The placebo is an oral capsule identical in appearance to the active intervention and contains 300 mg of starch. Participants will take one capsule orally once daily in the morning with water for 12 weeks.

Placebo (Inactive capsule)

Eligibility Criteria

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

You may qualify if:

• Healthy women aged 18-40 years with intact uterus and ovaries.
• Females with complaints of experiencing mild to moderate PMS confirmed by one baseline cycle using the DRSP.
• PSST sores consistent with PMS and not meeting criteria for severe PMS or PMDD.
• 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.

You may not qualify if:

• \. Participants taking any form of herbal extract in the last 3 months before study entry. 2. Participants who are on hormone replacement therapy (HRT) for more than 3 months. 3. Participants who are pregnant. 4. Participants with irregular menstrual cycles in the past 12 months (cycle length variability \>7 days), ≥2 missed cycles in the past 12 months, or amenorrhea ≥60 days. 5. Participants with Present active medical, surgical, and gynaecological problems. 6. Participants with a history of alcohol, tobacco dependence, or any substance abuse. 7. Participants who had undergone bilateral ovariectomy 8. Participants with history of breast or cervical carcinoma 9. Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate. 10. 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 results difficult. 11. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 12. Participants with demonstrated inability to comply with study procedures or follow-up visits. 13. Participants with inability to attend follow-up visit 14. Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective. 15. Patients who had participated in other clinical trials during the previous 3 months. 16. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.

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

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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 20, 2026
• Primary Completion (Estimated): June 22, 2026
• Study Completion (Estimated): July 8, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)