CTRI Number |
CTRI/2012/07/002775 [Registered on: 06/07/2012] Trial Registered Retrospectively |
Last Modified On: |
18/01/2012 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
A clinical study to see the effect of some Ayurvedic formulations in the patients of Bone loss. |
Scientific Title of Study
|
Clinical Evaluation of Laksha Guggulu and Mukta Shukti Pishti in the Management of Osteopenia/Osteoporosis. |
Trial Acronym |
ACT- OP-2010 |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Pradeep Dua |
Designation |
Research Officer (co-ordinator ACT project) |
Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058 Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058 West DELHI 110058 India |
Phone |
011-28525831 |
Fax |
011-28520748 |
Email |
duadrpradeep@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pradeep Dua |
Designation |
Research Officer (co-ordinator ACT project) |
Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058 Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058 West DELHI 110058 India |
Phone |
011-28525831 |
Fax |
011-28520748 |
Email |
duadrpradeep@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Pradeep Dua |
Designation |
Research Officer (co-ordinator ACT project) |
Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058 Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058 West DELHI 110058 India |
Phone |
011-28525831 |
Fax |
011-28520748 |
Email |
duadrpradeep@gmail.com |
|
Source of Monetary or Material Support
|
Support in terms of infrastructural facilities:
1. National Institute of Ayurveda (NIA), Jaipur.
2. Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola.
3. Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Hassan. |
|
Primary Sponsor
|
Name |
Department of AYUSH Ministry of Health Family Welfare Government of India |
Address |
Department of AYUSH, Ministry of Health & Family Welfare,
Government of India, IRCS Building, Red Cross Road, New
Delhi-110001 |
Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 3 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Prof H K Kushwaha Dr Uttam Kumar |
National Institute of Ayurveda (NIA), Jaipur |
Department of Shalya, Amer Road, Madhav Vilas Palace, Jaipur-302002 Jaipur RAJASTHAN |
0141-2785113 0141-2635709 drhkkushwah@gmail.com |
Dr Sanjeev Sharma Dr Dheeraj Mehra |
Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola |
Department of Shalya, Paprola, District Kangra-176115 Kangra HIMACHAL PRADESH |
9418079691 01894242064 sumansanjeevsuman@gmail.com |
Dr B J Gopikrishna Dr Brijesh Singh |
Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Hassan |
Department of Shalyatantra, Thannirohalla, B.M. Road, P.B. No.-64, Hassan-573201 Hassan KARNATAKA |
9886360901 08172-256464 drgkayu4u@rediffmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 3 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, National Institute of Ayurveda (NIA), Jaipur |
Approved |
Institutional Ethics Committee, Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola |
Approved |
Institutional Ethics Committee, SDM College of Ayurveda, Hassan |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Osteopenia/Osteoporosis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Laksha Guggulu |
Dose – 1gm (2 Tablets) twice daily
Dosage form - Tablet of 500 mg
Route of Administration – oral
Time of Administration-Twice a day after food
Anupana-Lukewarm Water
Packing form- Bottle containg 60 tablets
Duration of therapy-12 weeks |
Intervention |
Mukta Shukti Pishti |
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-Plastic jar of 7.5 gm containing 30 capsule
Duration of therapy-12 weeks |
Comparator Agent |
Not applicable |
Not applicable |
|
Inclusion Criteria
|
Age From |
45.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1 Patients of either sex between 45 to 65 years of age.
2 B.M.D.T-. Score of < -1
3 Willing and able to participate for 16 weeks |
|
ExclusionCriteria |
Details |
1. Patients who are consuming any drug which is known to affect bone metabolism for e.g. SERMs, bisphophonates, calcitonin, Vit.D (more than 60,000 units) and corticosteroids (more than 5mg/day of prednisolone or equivalent) for more than 3 months, methotrexate, anti- convulsants, diuretics, etc
2. Patients with history of Fragility Fracture.
3. Patients suffering from congenital disorders (Dysosteogenesis and Marfan’s Syndrome)
4. Patients with endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushing‘s syndrome)
5. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)
6. Patients suffering from Osteomalacia.
7. Patients whose Serum Ca++ level < 2.2 or > 2.6 mmol/L (< 9 or >10.5 mg/dL)
8. Patients suffering from Malabsorption syndrome
9. Patients who have undergone Organ transplantation
10. Patients who are immobilized since > 6 weeks
11. Patients with history of Long bone fracture in last 6 months.
12. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
13. Symptomatic patient with clinical evidence of Heart failure.
14. Patients with concurrent serious 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.
15. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
16. Alcoholics and/or drug abusers.
17. Patients with evidence of malignancy
18. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
19. Pregnant or lactating woman.
20. H/o hypersensitivity to any of the trial drugs or their ingredients
21. Patients who have completed participation in any other clinical trial during the past
six (06) months.
22. Any other condition which the P.I. thinks may jeopardize the study. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
• Change in Quality of Life index (QUALEFFO-41) |
At Baseline, at 84th day and at the end of follow up after 16 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
• Change in Bone Mineral Density (T-score) |
At Baseline and at the 84th day. |
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
21/12/2010 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
To be published after the completion of the clinical trials in all the three centers. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country. Laksha Guggulu, a polyherbal Ayurvedic formulation containing Laksha (Laccifer lacca), Asthisamhrt (Cissus quadrangularis), Asvagandha (Withania somnifera), Nagabala (Sida veronicaefolia) and Guggulu (Commiphora wightii). Mukta Shukti Pishti is air dried powder of Mukta and Shukti with the help of Gulab Jala. Laksha Guggulu and Mukta Shukti Pishti have been in use since ages and found to be useful in treating Osteopenia/Osteoporosis and promoting the health. The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who would be doing the clinical trials to scientifically study and validate the clinical efficacy and safety of these Ayurvedic formulations as a part of their Post Graduate (PG) Thesis. The Central Council for Research in Ayurvedic Sciences (CCRAS) is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project. |