An Open Label Single Arm Clinical Study To evaluate the efficacy of Vayasthapana Gana Kashayam in the managment of menopausal symptoms in peri menopausal women

INTRODUCTION AND SCOPE

Menopause and the preceding perimenopausal transition are increasingly recognized as significant global health challenges affecting women physical psychological and social well being. According to projections by the World Health Organization by the year 2030 more than one billion women worldwide will be aged fifty years or above experiencing menopause or its transitional phase.

Perimenopause is defined as the transitional period during which a woman body progresses toward menopause culminating in the final menstrual period. The onset of perimenopause is characterized by menstrual irregularities while menopause is confirmed retrospectively after twelve consecutive months of amenorrhea. This transitional phase is associated with progressive decline in ovarian function leading to reduced estrogen and progesterone secretion. Consequently women experience marked hormonal fluctuations that manifest as a wide range of vasomotor psychological urogenital and musculoskeletal symptoms.

The perimenopausal transition has often been described as a biological storm reflecting the complex interplay of endocrine physical and emotional changes that profoundly influence a woman personal familial and social life. Symptoms such as mood disturbances persistent fatigue sleep disorders and altered libido frequently strain marital relationships and interpersonal dynamics. Reduced work efficiency social withdrawal and declining self esteem further compromise overall quality of life.

Conventional management strategies particularly hormone replacement therapy have demonstrated efficacy in alleviating menopausal symptoms. However concerns regarding potential adverse effects and contraindications limit their suitability for all women. This has led to a growing global interest in safe natural and holistic therapeutic alternatives that support women through this physiological transition.

AYURVEDIC PERSPECTIVE

In Ayurveda ageing is described under the concept of Jara one of the Swabhavika Vyadhis denoting a natural and inevitable biological process. Menopause is regarded as a physiological milestone marking the onset of Jara Avastha. Women during this phase are described as Nishphala and Gatartava indicating cessation of fertility and decline in reproductive capacity which heralds the beginning of senescence.

Classical Ayurvedic texts describe Rajonivrutti as occurring around the age of fifty years correlating with the hormonal and reproductive decline recognized in modern physiology. Menopause is thus viewed as a natural transition from a Pitta dominant to a Vata dominant stage of life. The predominance of Vata Dosha in later years contributes to Dhatu Kshaya Sosha dryness reduced vitality and functional instability.

Madhava Nidana describes Jarasosha as a degenerative condition characterized by Vata Prakopa and Dhatu Kshaya leading to depletion of Bala Varna and Ojas. Clinical manifestations such as fatigue dryness of tissues reduced strength and emotional instability closely resemble the symptomatology observed during menopause.

RATIONALE OF THE STUDY

In this context Vayasthapana Gana one of the Rasayana Ganas described by Acharya Charaka holds special therapeutic relevance. It comprises ten medicinal plants Amalaki Phyllanthus emblica Haritaki Terminalia chebula Guduchi Tinospora cordifolia Rasna Pluchea lanceolata Aparajita Clitoria ternatea Punarnava Boerhavia diffusa Jeevanti Leptadenia reticulata Shatavari Asparagus racemosus Mandukaparni Centella asiatica and Sthira Desmodium gangeticum.

These drugs possess proven antioxidant Rasayana Vatashamaka and Dhatuvardhaka properties supported by various in vitro and in vivo studies. The term Vayasthapana literally denotes that which sustains youthfulness emphasizing preservation of tissue integrity vitality and functional balance.

Preliminary studies on Vayasthapana Gana have demonstrated promising outcomes in reducing menopausal symptoms and improving overall well being. However robust clinical evidence remains limited.

Therefore the present study is designed to evaluate the efficacy of Vayasthapana Gana Kashayam in the management of menopausal symptoms and enhancement of quality of life among perimenopausal women. This intervention may offer a safe natural and holistic alternative to conventional therapies supporting physical equilibrium emotional stability and overall health during this pivotal stage of life.

OBJECTIVES

Primary Objective To evaluate the efficacy of Vayasthapana Gana Kashayam in the management of menopausal symptoms among perimenopausal women.

Secondary Objective To evaluate the efficacy of Vayasthapana Gana Kashayam in improving quality of life among perimenopausal women assessed using MENQOL questionnaire.

HYPOTHESES

Null Hypothesis Vayasthapana Gana Kashayam has no significant effect on reducing menopausal symptoms or improving quality of life.

Alternate Hypothesis Vayasthapana Gana Kashayam significantly reduces menopausal symptoms and improves quality of life.

STATEMENT OF THE RESEARCH PROBLEM

Menopause and the perimenopausal transition represent a growing global health burden with millions of women experiencing distressing vasomotor psychological urogenital and musculoskeletal symptoms that markedly impair quality of life. Although conventional therapies such as hormone replacement therapy are effective their associated risks and contraindications necessitate the exploration of safer and holistic alternatives. From an Ayurvedic perspective menopause corresponds to Jara Avastha characterized by Vata predominance and Dhatu Kshaya. Despite the therapeutic potential of Vayasthapana Gana clinical evidence validating its efficacy remains limited. Hence the present study aims to scientifically evaluate the effectiveness of Vayasthapana Gana Kashayam in managing menopausal symptoms and improving quality of life in perimenopausal women.

REVIEW OF LITERATURE

Disease Review A comprehensive review of perimenopause menopause menopausal symptoms and the Ayurvedic concept of Rajonivrutti will be undertaken using classical Ayurvedic texts contemporary medical literature research articles and standard textbooks.

Drug Review A detailed review of Vayasthapana Gana will be conducted.

PHARMACEUTICAL STUDY

The study drug will be prepared at the Pharmacy of Indian Institute of Ayurved and Research Hospital Rajkot following Standard Operating Procedures. The Kashayam will be prepared according to Kwatha Kalpana guidelines as per the Ayurvedic Formulary of India. Raw drugs will be identified and authenticated using pharmacognostical parameters. A preliminary pharmaceutical study will be undertaken for preparation and standardization of the formulation.

MATERIALS AND METHODS

Study Design Open label single arm clinical study with pre and post treatment evaluation.

Sample Size Minimum of one hundred participants fulfilling inclusion and diagnostic criteria.

Study Setting Perimenopausal women attending the PTSR outpatient department of Indian Institute of Ayurved Research Hospital Rajkot and Glocal Ayurveda Medical College Mirzapur Pole Saharanpur Uttar Pradesh.

TREATMENT PROTOCOL

Drug Vayasthapana Gana Kashayam Dose fifty milliliters twice daily Time before food Route oral Duration three months twelve weeks

INFORMED CONSENT

Written informed consent will be obtained from all participants in accordance with World Health Organization Research Ethics Review Committee guidelines. The consent document will include a patient information sheet and certificate of consent.

DIAGNOSTIC CRITERIA

Diagnosis of perimenopause will be based on STRAW staging menstrual based reproductive stage.

Early menopausal transition Persistent difference of seven days or more in cycle length Late menopausal transition Amenorrhea of more than sixty days but less than twelve months

INCLUSION CRITERIA

Women aged forty to fifty five years Perimenopausal women fulfilling STRAW diagnostic criteria Menopause Rating Scale score nine or more at screening

EXCLUSION CRITERIA

Women with amenorrhea more than twelve months Women with surgical menopause Women on hormonal therapy Subjects already on treatment for menopausal symptoms Uncontrolled systemic illness

ASSESSMENT CRITERIA

The study will utilize Menopause Rating Scale questionnaire for assessment of menopausal symptoms. Overall efficacy will be assessed based on reduction in total Menopause Rating Scale score. Quality of life will be assessed using MENQOL questionnaire at baseline and after treatment.

CRITERIA FOR OVERALL ASSESSMENT OF THERAPY

Marked improvement More than seventy five percent relief Moderate improvement Fifty to seventy five percent relief Mild improvement Less than fifty percent relief Unchanged Less than twenty five percent relief

TIME POINTS

Assessment will be carried out at baseline and after completion of twelve weeks of treatment.

WITHDRAWAL CRITERIA

Subjects developing serious adverse events poor compliance or loss to follow up will be withdrawn from the study and referred to appropriate care centers.

STATISTICAL ANALYSIS

The collected data will be analyzed using descriptive statistics Student t test and other appropriate statistical methods