Clinical Trial Details (PDF Generation Date :- Tue, 06 Nov 2018 17:16:00 GMT) CTRI Number Last Modified On 03/02/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/01/005474 [Registered on: 29/01/2015] - Trial Registered Prospectively No Interventional Ayurveda Single Arm Trial STUDY OF SOME AYURVEDIC MEDICINES IN THE TREATMENT OF ASTHI KSHAYA(DECREASE OF BONE TISSUE) CLINICAL EVALUATION OF ABHADYA CHURNA AND MUKTASUKTI BHASMA IN THE MANAGEMENT OF OSTEOPENIA/OSTEOPOROSIS (ASTHI KSHAYA) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Source of Monetary or Material Support > CENTRAL COUNCIL OF RESEARCH IN AYURVEDIC SCIENCE(dePTOF AYUSH,mINISTRY OH health 7 family welfare)jaharlal NeheruBharatiya Chikitsha evam HomeopathyAnusandhan Bhawan,no61-65,Insitutional Area,Opp.D block,janakpuri,new Delhi. Type of Sponsor List of Countries of Principal Investigator Primary Sponsor Details CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES CENTRAL COUNCIL OF RESEARCH IN AYURVEDIC SCIENCE(dePTOF AYUSH,MINISTRY OH HEALTH 7 family welfare)jaharlal NeheruBharatiya Chikitsha evam HomeopathyAnusandhan Bhawan,no61-65,Insitutional Area,Opp.D block,janakpuri,new Delh Research institution and hospital DRDIPSUNDAR SAHU OPD(ROOM NO-13) AND IPD(ROOM NO-52) OF NATIONAL RESEARCH INSTITUTE OF DRUGS DEVELOPMENT NO of Site Site Phone/Fax/ BHARATPUR,BHUBAN ESWAR, PIN-751009 0674-2386702 0674-2386702 of Committee Approval Status Date of Approval Is Independent Ethics Committee? NRIADD ETHICAL COMMITTEE Status Health Type Patients Approved 14/03/2014 No Date No Date Specified Condition Type Details Intervention ABHADYA CHURNA AND MUKTA SUKTI BHASMA 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. Abhadya Churna (AFI -Part III-Vol.- I Pg.123-124). Dose 5 gm (1 Sachet of 5gm) twice daily Dosage form 30 Sachet of 150 gms Oral Route of Administration Oral Time of Administration Twice a day after food Anupana Lukewarm Water Packing form A Hard cartoon Box of 150 gm (containing 30 page 2 / 5
Inclusion Criteria Comparator Agent Age From Age To Gender Details 40.00 Year(s) 65.00 Year(s) Both Inclusion Criteria Sachet of 150 gms each) Duration of therapy 12 weeks MuktaSukti Bhasma ((AFI-PartI--Page.238-239). Dose 250 mg twice daily Dosage form Capsule of 250 mg Route of Administration Oral Time of Administration Twice a day after food Anupana Lukewarm Water Packing form A plastic jar of 7.5 gm(containing 30 capsules of 250 mg each Duration of therapy 12 weeks 1 Patients of either sex between 40 to 65 years of age. 2 B.M.D -T. Score between ( -1 to -3 ) on DEXA Scan. 3 Willing and able to participate for 14 weeks. Details 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 page 3 / 5
22. Any other condition which the investigator thinks may jeopardize the study. Method of Generating Random Sequence Method of Concealment Blinding/Masking Case Record Numbers Open Label Primary Outcome Outcome Timepoints 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 Outcome Timepoints Change in Quality of Life index (QUALEFFO-41) Change in Bone Specific Alkaline Phosphatase Total Study Period 24 months Washout (if required) 2 weeks Recruitment 14 months Treatment Period 12 weeks Follow-Up Period 2 weeks Statistical Analysis 3 months Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=65 Sample Size from =65 01/07/2015 No Date Specified Years=2 Months=0 Days=0 Not Yet Recruiting "NONE YET" 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 n 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 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. page 4 / 5
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