abhadya chura and mukta bhasma in the management of Ashthi Kshaya.

Phase 3

Completed

Conditions: Osteoarthritis, unspecified site. Ayurveda Condition: ASTHIGATAVATAH, patients of either sex inbetween 45 to 65 years. BMDT score -1,

Registration Number: CTRI/2017/05/008614

Lead Sponsor: CCRAS New Delhi

Brief Summary: *Asthi kshaya* is a condition in which there is decrease in the *Asthi dhatu* (Bone tissue) leading to many undesirable effects. It can be compared with Osteoporosis in which there is decrease in the Bone Mineral Density (BMD) leading to increased risk of fractures. The Primary aim of the study is to stop further loss of mineral density of bone and to development of ossification through the compound formulations projected, since which has probable effect of Osteogenic effect which can be experimented in the different studies. *MuktaSukti Bhasma* (Ref- AFI Part-I Page-238- 239) has been experimented is natural source of rich calcium widely used in Traditional system of Indian medicine as a supplement in the treatment of Bone metabolic disorder associated with calcium deficiency.(Ref.Pharmacological Research Volume 48,Issue-6,December 2003,Pages 593-599).Sudha barga compounds having therapeutically rich in calcium (Ref-International journal of Pharmacy ISSN-2230-8407).However the compound effect of *Abhadya churna* has not been taken into study neither or not experimented so far. But it has been indicated for *Majjagata Vata*(Bone marrow related) disorder. (Ref- AFI â€“Part-III ,VOl-1but the all the individual ingredients of Abhadya churna have already been proven to be efficacious in bone marrow related disorder or improvement of bone health.Abhadya churna content The Hypothesis of evaluating the Osteogenic effect from both the combinations, it has been decided to take a study of both the combined formulations i.e. *Abhadya Churna* and *Prabal Bhasma* in selected cases of Osteoporosis/Osteopenia*(Asthi Kshaya*). The results will be assessed as per the standard guidelines. It is a prospective clinical trial of classical Ayurveda medicine used in osteopenia since long. It is effort to create evidence of Ayurveda medicine and access the safety and efficacy of trial drug in osteopenia . The project was funded by CCRAS. Special CRF was prepared and NABH accredited laboratory selected to conduct the test. Both subjective and objective parameters will compared with base line and after 12 weeks of treatment. The primary objective to note the quality of life index(QUALEFF0-41)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

BMD T score less than -1.

Exclusion Criteria

fragidity of bone, endocrine dis0rders,patients having poorly controlled hypertension, serum calcium less than 2.6 and more than 10.5 mg/dl.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in quality of life index,	12 weeks

Secondary Outcome Measures

Name	Time	Method
change BMD Tscore, Bone specific alkaline phospatase change	12 weeks

Trial Locations

Locations (1): CARIHD, Bhubaneswar
🇮🇳
Khordha, ORISSA, India
CARIHD, Bhubaneswar
🇮🇳Khordha, ORISSA, India
Dr Ashok Kumar Panda
Principal investigator
9434631670
akpanda_06@yahoo.co.in