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CTRI Number  CTRI/2017/05/008662 [Registered on: 25/05/2017] Trial Registered Retrospectively
Last Modified On: 06/11/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Study on Osteoporosis 
Scientific Title of Study   Clinical evaluation of Laksha Guggulu, Muktasukti Bhasma in the management of Osteopeniea/ Osteoporosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Goli Penchala Prasad 
Designation  Research Officer (Ayurveda) 
Affiliation  CCRAS 
Address  Regional Ayurveda Research Institute for Skin Disorders New Rajiv nagar Payakapuram Vijayawada

Krishna
ANDHRA PRADESH
520015
India 
Phone  9441654500  
Fax  8662402144  
Email  drprasadgoli@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Goli Penchala Prasad 
Designation  Research Officer (Ayurveda) 
Affiliation  CCRAS 
Address  Regional Ayurveda Research Institute for Skin Disorders New Rajiv nagar Payakapuram Vijayawada


ANDHRA PRADESH
520015
India 
Phone  9441654500  
Fax  8662402144  
Email  drprasadgoli@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Goli Penchala Prasad 
Designation  Research Officer (Ayurveda) 
Affiliation  CCRAS 
Address  Regional Ayurveda Research Institute for Skin Disorders New Rajiv nagar Payakapuram Vijayawada


ANDHRA PRADESH
520015
India 
Phone  9441654500  
Fax  8662402144  
Email  drprasadgoli@yahoo.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences JLNBCEH Anusandhan Bhawan 61-65, Institutional Area Opp. D Block, Janakpuri New Delhi-110058  
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Jawaharlal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan 61-65, Institutional Area, Opposite D-Block, Janakpuri, New Delhi - 110058  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Achintya Mitra  Central Ayurveda Research Institute for Drug Development  Central Ayurveda Research Institute for Drug Development, 4-CN Block, Sector – V, Bidhannagar, Kolkata – 700 091
Kolkata
WEST BENGAL 		 9836727927
3323673881
achintyamitra1@gmail.com 
Dr Goli Penchala Prasad  Regional Ayurveda Research Institute for Skin Disorders  New Rajiv Nagar Payakapuram Vijayawada
Krishna
ANDHRA PRADESH 		 9441654500
8662402144
drprasadgoli@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Osteoporosis and Osteopenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laksha guggulu and Mukktasukti bhasma  1. Laksha guggulu (AFI,Vol - I, page No: 70, API Part II Vol.II) Dose : 1 gm TDS Dosage form : Tablet Route of Administration : Oral Time of Administration : Thrice a day after food Anupana : Sukoshna jala Duration of therapy : 12 weeks 2. Muktashukti bhasma (AFI - Vol I, page No: 238 -239) Dose : 250mg. BD Dosage form : Capsule Route of Administration : Oral Anupana : Milk Time of Administration : Twice a day Duration of therapy : 12 weeks  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients of either sex with age above 45years and upto 70 years.
2. B.M.D.T. Score ( -1 to -3) on DEXA Scan
3. Patient willing to participate in the clinical trial
 
 
ExclusionCriteria 
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 suffering from Osteomalacia.
6. Patients suffering from Malabsorption syndrome
7. Patients who have undergone Organ transplantation
8. Patients who are immobilized since > 6 weeks
9. Patients with history of bone fracture in last 6 months.
10. Patients with evidence of malignancy
11. Pregnancy and lactation
12. Patients who cannot report in person once in 2 weeks in the OPD
13. Patients with poorly controlled Hypertension ( >160/100 mmHg)
14. Patients with poorly controlled Diabetes Mellitus having Hb A1C of >8
15. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
16. Patients with history of Urolithiasis.
17. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dl), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
18. Alcoholics, smokers, and/or drug abusers
19. H/o hypersensitivity to any of the trial drugs or their ingredients
20. Patients who have completed participation in any other clinical trial during the past six months.
21. Patients on calcium and Vitamin D supplementation
22. Known cases of Paget’s disease of bone.
23. Any other condition which the Investigator 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 
Improvement in BMDT  84th day 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in clinical parameters  84 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   22/03/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Will be published after completion of the study 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

For the scientific validation of classical Ayurvedic formulations a multi centric clinical trial has been initiated for the management of Asthisaushirya (Ostoporosis/Osteopenia) as an activity under Intra Mural Clinical Research Programme. Ayurvedic medicines Laksha guggulu, Muktasukthi Bhasma selected for the study. Treatment will be given for 12 weeks, Sample size is 60. Duration of the treatment is 12 weeks. Total study period is 2 years. 

 
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