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CTRI Number  CTRI/2014/02/004372 [Registered on: 03/02/2014] Trial Registered Prospectively
Last Modified On: 30/01/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Pain Management in Osteoarthritis through Homoeopathy 
Scientific Title of Study   Comparing individualized homoeopathy with placebo in managing pain of knee osteoarthritis: a double blind randomized controlled trial 
Trial Acronym  OA-RCT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr RK Manchanda 
Designation  Director General 
Affiliation  Central Council for Research in Homoeopathy 
Address  Central Council for Research in Homoeopathy, 61-65, Institutional area, Janak Puri, Delhi

South West
DELHI
110058
India 
Phone  011-28525523  
Fax  011-28521060  
Email  dgccrh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anil Khurana 
Designation  Assistant Director 
Affiliation  Central Council for Research in Homoeopathy 
Address  Central Council for Research in Homoeopathy, 61-65, Institutional area, Janak Puri, Delhi

South West
DELHI
110058
India 
Phone  09911127619  
Fax  011-28521060  
Email  ccrhindia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anil Khurana 
Designation  Assistant Director 
Affiliation  Central Council for Research in Homoeopathy 
Address  Central Council for Research in Homoeopathy, 61-65, Institutional area, Janak Puri, Delhi

South West
DELHI
110058
India 
Phone  09911127619  
Fax  011-28521060  
Email  ccrhindia@gmail.com  
 
Source of Monetary or Material Support  
Approved budget of CCRH 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy 
Address  Central Council for Research in Homoeopathy, 61-65, Institutional area, Janak Puri, Delhi 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohan Singh  Central Research Institute (Homoepathy)  A-1/1. Sector-24, Noida
Gautam Buddha Nagar
UTTAR PRADESH 		 09868602790

crihnoida@gmail.com 
Dr Gurudev Chaubey   Clinical Research Unit (Homoeopathy)  Gokhel Road (Near Matri Bhandar), Arobindopally, Siliguri – 734006.
Jalpaiguri
WEST BENGAL 		 03532596065

gurudev.choubey@gmail.com 
Dr AK Gupta  Regional Research Institute (Homoeopathy)  C – 12, Lane -1, Sector-1 Below B.C.S. New Shimla - 171009.
Shimla
HIMACHAL PRADESH 		 09415109650

rrishimla@gmail.com 
Dr Kishan Bhanoth  Regional Research Institute (Homoeopathy)  Dr GGH Medical College Campus, Eluru Road, Gudivada -521301
Krishna
ANDHRA PRADESH 		 09000394815

rrigudivada@gmail.com 
Dr Muralidharan  Regional research Institute (Homoeopathy)  MTNL Hall no. 4, Shopping Centre, Sector - 9, CBD Belapur, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA 		 09869321223

rrihmumbai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee of CCRH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Osteoarthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicine  Any one of the following homoeopathic medicine i.e. Rhus tox., Bryonia alba, Causticum, Pulsatilla, Arnica, Calcarea carb., Sulphur, Calcarea flour based on individualization as detailed in the standard Materia Medica will be used for 8 weeks, starting from 30 potency. The potency will be raised sequentially as per homoeopathic principles.  
Comparator Agent  Placebo  83.1% v/v ethyl alcohol (used as a vehicle to prepare homoeopathic medicines) will be used as placebo. The placebo will also be dispensed in sugar globules of standard size 30.  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients above the age of 50 years, presenting with knee pain and evidence of osteophytes in the knee radiograph 
 
ExclusionCriteria 
Details  • Rheumatoid factor more than 1:40 titre
• ESR more than 40mm/hour
• Serum uric acid level >7 mg/dL in men or >6 mg/dL in women
• Severe degeneration of knee joint with marked joint narrowing, varus, or valgus deformity of knee (> 12°); evidenced by imaging or other evidences and requiring surgical intervention
• Non-ambulant patients
• Self-reported joint disorders (e.g. inflammatory joint disease, specific arthropathy, severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs) other than OA
• IA injections within 2 weeks prior to study entry
• Cases with other systemic unevaluated or uncontrolled diseases like diabetes mellitus, hypertension, or other cardiovascular, renal, gastro-intestinal, endocrinal, gynecological diseases etc. or systemic infections affecting quality of life or on other treatment therapies
• Psychiatric illness
• Patients with any vital organ failure
• Recent knee surgery within last 6 months
• Cases with transplanted knees
• History of homeopathic treatment for any chronic disease within last 6 months
• Self-reported immune-compromised states
• Alcohol and/or drug addiction or dependence
• Cases with controlled/uncomplicated hypertension, diabetes mellitus, etc. will not be excluded. Patients on life-saving conventional drug therapies, e.g. anti-diabetics, anti-hypertensives, thyroid drugs etc. for co-morbidities under control, will be continued.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in pain, stiffness, limitation of movement on an identified scale
Change in pain measured on identified scale (OARSI - OMERACT constant/intermittent pain measure)  		 every 15 days till 2 months of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Change in requirement of NSAIDs during the course of treatment
• Incidence of any adverse events/severe adverse events during the period of treatment 		 every 15 days till 2 months of treatment 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 3 
Date of First Enrollment (India)   17/02/2014 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   will be published as per the publication policy of the Council 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The study will be conducted with an objective to compare the efficacy of individualized homoeopathic treatment with placebo in pain management of knee joint osteoarthritis. 200 patients above the age of 50 years diagnosed with knee osteoarthritis (as per ACR criteria) will be enrolled in the study. Study is a multi-centric double blind placebo controlled trial, where individualized homoeopathic medicine/ placebo will be given and patient will be assessed every 2 weeks for 2 months. The regular medications of the patients, if any will continue throughout the period of trial. Outcome will be measured in terms of change in knee pain, stiffness, limitation of movement and use of NSAIDs.

 
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