Clinical Study to evaluate efficacy of Ayurvedic medicated enema with ayurvedic preparation in the management of osteoporosis

Phase 1

Completed

• Conditions: Diseases of the musculoskeletal system and connective tissue,

• Registration Number: CTRI/2019/08/020840
• Lead Sponsor: Dr D Y Patil University

Brief Summary

This study is undertaken to check the role of Panchatikta ksheera basti and ayurvedic preparation in the management of the disease condition of Asthikshaya ( osteoporosis) with pathological investigations before and after. The total duration of the study is 30 days.

Enrollment of the patients will be done after CTRI registration



The Total no of 30 Patients enrolled in the study .

Group A was administered with Panchatikta Ksheera Basti and Praval Panchamruta 250 mg BD for 30 days with initial deepana -pachana drugs for 3 days. Out of which 3 patients were considered dropout as they discontinued the follow up. Group B was given with Organic Calcium Supplement+D3 orally for 30 days. 1 patient was considered dropout in Group B due to irregular follow up. Total 26 patients completed the study

The results statistically showed better results in Group A than in Group B in some parameters.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-22
• Study Completion: 2021-11-06
• Last Update Posted: 2024-01-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Patients with classical sign and symptoms of of asthikshaya like asthishula, toda, sandhi shaithilya, kesha, loma, nakha, danta vikara and patana, daurbalya, rukshata etc.
• Osteopenic /Osteoporotic patients of either gender whose BMD (t score) is equal to or less than -1.

Exclusion Criteria

• 1.Patients suffering from neoplasm of bone.
• 2.Known case of Diabetes Mellitus, Thyrotoxicosis, Hyper Parathyroidism, Addison’s disease, Paget’s disease, Cushing’s syndrome, Tuberculosis of bone , Osteomalacia, Chronic renal, Hepatic, cardiac failure 3.Rheumatoid Arthritis, Gouty Arthritis and any other long standing systemic disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in functional and physical activities of the patients with improved daily lifestyle	30 days

Secondary Outcome Measures

Name	Time	Method
Improvement in their daily lifestyle	30 days

Trial Locations

Locations (1)

Dr D Y Patil College of Ayurved & Research Center; 🇮🇳 Pune, MAHARASHTRA, India

Dr D Y Patil College of Ayurved & Research Center

🇮🇳Pune, MAHARASHTRA, India

Varghese Jibi

Principal investigator

8983478062

vjayu82@gmail.com