Evaluation of efficacy and safety of ASPURUS for management of menopausal symptoms

Phase 4

Recruiting

Conditions: Menopausal and other perimenopausal disorders. Ayurveda Condition: ARTAVAKSHAYAH,

Brief Summary: Menopause is defined as decreased ovarian follicular function and estrogen level, which may begin at mid-30s or late mid-50s. Approximately, 95% of the women in some communities are in menopause, and are predicted to reach 1.2 billion by 2030, with an annual increase of 47 million new cases.

Hormonal therapy and non-hormonal treatments (Anti-depressants) are intensive approaches to prevent and reduce menopausal symptoms that are accompanied by many adverse effects, including an increased risk of uterine & ovarian cancer and sleep disorders, dizziness, nausea, fatigue, etc. Women have been choosing alternative medicine since itâ€™s affordable and safer. It boosts general health and reduces disease symptoms and ADR.

Shatavari (*Asparagus racemosus Wild*) has long been used as an Ayurvedic herb for womenâ€™s health, Steroidal saponins are thought to be the principal bioactive constituents of Shatavari root. *Asparagus racemosus* contains phytochemical constituents such as steroidal saponins, alkaloids, quercetin and glycosides of quercetin. In Ayurvedic medicine, it has been used to treat conditions relating to the female reproductive system including menopause, the immune system and the nervous system.

The purpose of this post marketing study is to investigate the safety and efficacy of Shatavari on reducing menopausal symptoms and regulating HPO Axis.

Recruitment & Eligibility

Inclusion Criteria

1.Female subjects aged 40 years to 65 years .
2.Subjects who are experiencing menopausal symptoms such as hot flushes, night sweats, anxiety, depression, insomnia etc., as diagnosed by the study investigator.
3.Subjects who are otherwise healthy except for the menopausal symptoms.
4.Subjects or their legally acceptable representative are willing to provide informed written consent and agree to adhere to the study procedures.

Exclusion Criteria

1.Pregnant, planning to become pregnant or breastfeeding women.
2.Subjects who have undergone partial or complete hysterectomy 3.Subjects who are undertaking hormone replacement therapy or any other herbal medicine treatment for menopausal symptoms.
4.Current or history of a serious illnesses in the last three months which as per the study investigator will impact the study outcomes.
5.History of or current Alcohol or substance abuse 6.Allergy or sensitivity to any of the ingredients in the study treatment 7.Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly.
8.Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.

Primary Outcome Measures

Name	Time	Method
Change in total score of Utian Quality of Life (UQOL) at day 30 & 60 as compared to baseline	baseline, day 30 & day 60

Secondary Outcome Measures

Name	Time	Method
Change in individual domain scores of UQOL at day 30 & 60 as compared to baseline	baseline, day 30 & day 60
Change in Menopause Symptom status, telephonically assessed using 5-pont Likert Scale at Day 7 & Day 14 & visit assessment at day 30 & day 60 as compared to baseline	baseline, day 7, day14, day 30 & day 60
Change in 21 item Depression, Anxiety & Stress Scale (DASS-21) Score at day 30 and 60 as compared to baseline	baseline, day 30 & day 60
Change in Regensburg Insomnia Scale score at day 30 & day 60 as compared to baseline	baseline, day 30 & day 60
Change in mean serum levels of estradiol & progesterone at day 60 as compared to baseline	baseline, day 30 & day 60
Satisfaction with treatment captured using Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) at day 30 & day 60	day 30 & day 60

Locations (2): Good Life Hospital
🇮🇳
Krishna, ANDHRA PRADESH, India
Ravi Nursing Home
🇮🇳
Guntur, ANDHRA PRADESH, India
Good Life Hospital
🇮🇳Krishna, ANDHRA PRADESH, India
Dr G V Sugandha
Principal investigator
7893062708
drsugandhacr@gmail.com