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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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