STUDY OF SOME AYURVEDIC MEDICINES IN THE TREATMENT OF ASTHI KSHAYA(DECREASE OF BONE TISSUE)

Phase 3

Not yet recruiting

• Conditions: Patients of either sex with in the age group of 40-65 years of agecomplaining of Bone pain and decaying BMD score between -1 to -3 on DEXA scan selected for trial perticipent.

• Registration Number: CTRI/2015/01/005474
• Lead Sponsor: CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES

Brief Summary

*Asthi kshaya* is a condition inwhich there is decrease in the *Asthi dhatu* (Bone tissue) leading to manyundesirable effects. It can be compared with Osteoporosis in which there is decreasein the Bone Mineral Density (BMD) leading to increased risk of fractures. The Primary aim of thestudy is to stop further loss of mineral density of bone and to development ofossification through the compound formulations projected, since which hasprobable effect of Osteogenic effect which can be experimented in thedifferent  studies. *MuktaSukti Bhasma*(Ref- AFI Part-I Page-238- 239) has been experimented is natural source of richcalcium widely used in  Traditionalsystem of Indian medicine as a supplement in the treatment of Bone metabolicdisorder associated with calcium deficiency.(Ref.Pharmacological ResearchVolume 48,Issue-6,December 2003,Pages 593-599).Sudha barga compounds havingtherapeutically rich in calcium (Ref-International journal of PharmacyISSN-2230-8407).However the compound effect of *Abhadya churna* has notbeen taken into study neither or not experimented so far. But it has beenindicated for *Majjagata Vata*(Bonemarrow related) disorder. (Ref- AFI –Part-III ,VOl-1butthe all the individual ingredients of Abhadya churna have already been provento be efficacious in bone marrow related disorder or improvement of bone health.Abhadyachurna content The Hypothesis of evaluatingthe Osteogenic effect from both the combinations, it has been decided to take astudy of both the combined formulations i.e. *Abhadya Churna* and *PrabalBhasma* in selected cases of Osteoporosis/Osteopenia *(Asthi Kshaya*).  The results will be assessed as per thestandard guidelines.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-07
• Last Update Posted: 2015-03-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• 1Patients of either sex between 40 to 65 years of age.
• Score between ( -1 to -3 ) on DEXA Scan.
• 3Willing and able to participate for 14 weeks.

Exclusion Criteria

• Exclusion Criteria 1.Patients who are consuming corticosteroids (more than 5mg/day of prednisolone or equivalent) for more than 3 months 2.Patients with history of Fragility Fracture.
• 3.Patients suffering from congenital disorders related to bone (Dysosteogenesis, Marfan’s Syndrome, etc.) 4.Patients with (Hypothyroidism and Hyperthyroidism, Hypoparathyroidism and Hyperparathyroidism, Cushing‘s syndrome) 5.Patients with unstable CV diseases 6.Patients suffering from Osteomalacia.
• 7.Patients suffering from Malabsorption syndrome 8.
• Patients who have undergone Organ transplantation 9.Patients who are immobilized since > 6 weeks 10.Patients with history of bone fracture in last 6 months.
• 11.Patients with concurrent serious cardiac, Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S.
• creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
• 12.Patients with Diabetes Mellitus 13.Alcoholics and/or drug abusers.
• 14.Patients with evidence of malignancy 15.Patients suffering from major systemic illness necessitating long term drug treatment/Auto-Immune disorders (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 16.Pregnant or lactating woman.
• 17.H/o hypersensitivity to any of the trial drugs or their ingredients 18.Patients who have completed participation in any other clinical trial during the past Six (06) months.
• 19.Patients on calcium and Vitamin D supplementation.
• 20.Patients with history of Urolithiasis.
• 21.Known cases of Paget’s disease of bone 22.Any other condition which the investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Serum – Osteocalcin level from Baseline to end of study	With in 12 weeks of study period we can observe the change of BMD tscore,Change in Bone specific alkaline Phosphatase and change in Quality of life index.

Secondary Outcome Measures

Name	Time	Method
•Change in Quality of Life index (QUALEFFO-41)	•Change in Bone Specific Alkaline Phosphatase

Trial Locations

Locations (1)

OPD(ROOM NO-13) AND IPD(ROOM NO-52) OF NATIONAL RESEARCH INSTITUTE OF DRUGS DEVELOPMENT; 🇮🇳 Khordha, ORISSA, India

OPD(ROOM NO-13) AND IPD(ROOM NO-52) OF NATIONAL RESEARCH INSTITUTE OF DRUGS DEVELOPMENT

🇮🇳Khordha, ORISSA, India

DRDIPSUNDAR SAHU

Principal investigator

drdssahu@gmail.com