Shatavari Root Extract for Perimenopausal Symptoms

Официальное название

Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract for Treatment of Perimenopausal Symptoms in Women: A Randomized, Double-Blind, Parallel, Placebo-Controlled Study

Обзор

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.

Подробное описание

Perimenopause is characterized by fluctuating estrogen levels that contribute to vasomotor symptoms, mood disturbances, sleep disorders, and reduced quality of life. Shatavari (Asparagus racemosus) is a traditionally used Ayurvedic herb known for its adaptogenic and phytoestrogenic properties, supporting hormonal balance and stress regulation.

This multi-center, prospective, randomized, double-blind, parallel-group study will enroll 160 perimenopausal women in India and the United States. Eligible participants will be randomized in a 1:1 ratio to receive either a standardized Shatavari root extract capsule (300 mg/day) or a matched placebo for 12 weeks. Primary efficacy will be assessed using the Menopause Rating Scale (MRS). Secondary outcomes include menopause-specific quality of life, hot flash interference, perceived stress, mood, sleep quality, and salivary cortisol measures. Safety will be evaluated through laboratory investigations and monitoring of adverse events.

Вмешательства

• Пищевая добавка Shatavari (Asparagus racemosus) Root Extract
  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.
• Другое Placebo Capsule
  An inert starch-filled capsule identical in appearance, color, and packaging to the active intervention, administered once daily for 12 weeks to maintain blinding.

Первичные конечные точки

• Change in Menopause Rating Scale (MRS) Total Score [Срок оценки: Baseline, Week 4, Week 8, Week 12]

Вторичные конечные точки (12)

• Change in Menopause-Specific Quality of Life (MENQOL) Scores [Срок оценки: Baseline, Week 4, Week 8, Week 12]
• Change in Hot Flash-Related Daily Interference Scale (HFRDIS) Scores [Срок оценки: Baseline, Week 4, Week 8, Week 12]
• Change in Perceived Stress Scale (PSS-10) Scores [Срок оценки: Baseline, Week 4, Week 8, Week 12]
• Change in Pittsburgh Sleep Quality Index (PSQI) Scores [Срок оценки: Baseline, Week 4, Week 8, Week 12]
• Change in Profile of Mood States (POMS) Scores [Срок оценки: Baseline, Week 4, Week 8, Week 12]
• Change in Salivary Cortisol Awakening Response (CAR) [Срок оценки: Baseline and Week 12]
• Change in Bedtime Salivary Cortisol Levels [Срок оценки: Baseline and Week 12]
• Change in Liver Function Test Parameters (ALT, AST, ALP, Bilirubin) [Срок оценки: Baseline and Week 12]
• Change in Renal Function Test Parameters (Serum Creatinine, BUN) [Срок оценки: Baseline and Week 12]
• Change in Thyroid Function Test Parameters (T3, T4, TSH) [Срок оценки: Baseline and Week 12]
• Incidence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Baseline, Week 4, Week 8, Week 12]
• Incidence of Treatment-Emergent Serious Adverse Events (TESAEs) [Срок оценки: Baseline, Week 4, Week 8, Week 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.
• Patients who have any clinical condition, according to the investigator, who does not allow safe fulfilment of clinical trial protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• San Francisco Research Institute — San Francisco

Идентификаторы

NCT: NCT07441109 · Ixo/2025/1341/SHT/Perime/GB/08

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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