Ayurveda treatment for Post Menopausal Women

Phase 3

Not yet recruiting

Conditions: Disorder of bone density and structure, unspecified. Ayurveda Condition: ASTHISOSHAH,

Registration Number: CTRI/2025/04/085232

Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary: Osteopenia is a clinical term used to describe a decrease in bone mineral density (BMD) below normal reference values, yet not low enough to meet the diagnostic criteria to be considered osteoporotic . Osteopenia, as defined by the World Health Organization (WHO), is a t-score between -1 to -2.5, while values less than -2.5 are diagnostic for osteoporosis. Decreasing BMD values are reflective of an underlying disruption in the microarchitecture of bone and osteopenia, and osteoporosis is considered quantitative, not qualitative, disorders of bone mineralization. While it is estimated that heritable factors dictate up to 80% of our ability to achieve and maintain optimal bone mineralization levels, modifiable factors attributed to the rate of natural bone mass reduction into adulthood include weight-bearing exercises, nutrition status (adequate calcium and vitamin D daily intake), body mass, and hormonal milieu. Postmenopausal women are more likely to develop osteoporosis, which not only causes morbidity but also has a substantial negative influence on their quality of life. It is necessary to evaluate the quality of life of women with reduced BMD before fractures occur, to aid development of health education aiming to reduce the incidence of osteoporosis and prevent fractures.

Since there is decrease of bone tissue in this disease, it can be considered as Asthi-Majjakshaya because of its core of pathogenesis: 1) degeneration of bone tissue and 2) vitiation of Vata .A few studies on the use of herbal and herbo mineral drugs for the treatment of osteopenia/osteoporosis have been conducted before. Ayush Osto is a coded Ayurvedic formulation for the management of Asthikshaya (Osteoporosis & Osteopenia undertaken for drug development by the Council through a systematic process of drug development viz. drug standardization and experimental toxicity studies [Acute toxicity in mice, repeated dose toxicity (28 days and 90 days) in wistar rats.] The test drug was found safe at different dose levels.

Keeping in view of the above scenario, this multicentric study has been designed to evaluate the effect of Ayush Osto in improving bone mineral density.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 110

Inclusion Criteria

i.Women between 50 and 70 years with history of spontaneous amenorrhea for equal or more than 12 months.
B.M.D. T score between -1.0 and -2.5 measured by DXA Scan of neck of femur or lumbar spine.

Exclusion Criteria

1.Patients with a history of congenital disorders related to bone like Dysosteogenesis, Marfans Syndrome, Osteomalacia and Pagets disease.
2.Patients with a history of Endocrinal disorders like Thyroid and parathyroid dysfunction, Hyperprolactinemia and Cushings syndrome.
Patients with history of Malabsorption syndrome.
5.Patients with a history of any Malignancy.
6.Known cases of uncontrolled diabetes mellitus with HbA1c more than 8 percent, uncontrolled hypertension with BP equal or more than 160 per 100 mm Hg, Renal dysfunction defined as Serum creatinine more than 1.2 mg per dl, Hepatic dysfunction defined as AST and ALT more than 2 times of the normal upper limit, cardiac dysfunction, urolithiasisis and any other condition that may jeopardize the study.
7.Patients on calcium and Vitamin D supplementation or any osteopenia treatment or hormone replacement therapy.
8.Patients who are participating in any clinical trial currently or have completed participation in any other clinical trial during the past 6 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in bone mineral density	At Baseline, 90th day( for every 10th patient) and 180th day assessed by DXA scan.

Secondary Outcome Measures

Name	Time	Method
i.Change in hematological & biochemical parameters (Liver function test & renal function tests)	ii.Assessment of the tolerability of the Ayurveda therapeutic regimen through reported incidence of adverse events during the study period.

Trial Locations

Locations (2): All India Institute of Ayurveda
🇮🇳
South, DELHI, India
Parul Institute of Ayurved and Research
🇮🇳
Vadodara, GUJARAT, India
All India Institute of Ayurveda
🇮🇳South, DELHI, India
Dr Kamini Dhiman
Principal investigator
8920900968
kd44ayu@yahoo.co.in