Effect of Asthisamharadi churna in the management of Osteoporosis in Perimenopuase women.

Phase 2

Not yet recruiting

• Conditions: Age-related osteoporosis without current pathological fracture. Ayurveda Condition: ASTHIKSHAYAH,

• Registration Number: CTRI/2023/07/055298
• Lead Sponsor: Dr Inchara P

Brief Summary

- Perimenopause is  an ill-defined time period that surrounds the final years of a woman’s reproductive life. It begins with the first onset of menstrual irregularity and ends after 1 year of amenorrhea has occurred, thereby defining the final menstrual period

- During this transition, women experience multitude of symptoms that may not be life-threatening but have a negative impact on the quality of life, physical and mental health

- Out of 230 million Indians expected to be over age of 50 years in 2015, 20%, ie, ~46 million, were women with osteoporosis

- *Asthisamhaaraadi* *Churna*  is a formulation used in *Asthi Kshaya* with qualities like *Vatahara* and *Balya* in *Jara*, which could prove to be beneficial in the management of the same

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-17
• Study Start: 2023-07-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Subjects showing signs of menopause i.e. stage -2 (early menopause stage) and stage -1 (late menopause stage) of STRAW classification. 2. Subjects complaining symptoms like : joint pain, back ache, pain in bones (which will be later confirmed by BMD) 3. Subjects having BMD score ( T score <.

Exclusion Criteria

• 1. Subject aged less than 35 years and above 55 years. 2. Subjects undergoing HRT. 3. Subjects of known case of Renal calculi. 4. Subjects of known case of Osteomalacia, Rickets. 5. Subjects of known case of Thyroid dysfunction. 6. Subjects of known case of IHD. 7. Subjects having BMD score (‘T’ score less than.
• 2.5 SD with fracture).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement in the BMD score	4 weeks

Secondary Outcome Measures

Name	Time	Method
improvement in tiredness, weakness of joint, back ache	90 days

Trial Locations

Locations (1)

Sri Sri College of Ayurvedic Science and Research; 🇮🇳 Bangalore, KARNATAKA, India

Sri Sri College of Ayurvedic Science and Research

🇮🇳Bangalore, KARNATAKA, India

Dr Inchara P

Principal investigator

9986342595

incharap.456@gmail.com