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CTRI Number  CTRI/2025/04/084605 [Registered on: 11/04/2025] Trial Registered Prospectively
Last Modified On: 15/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Acupuncture and Osteoarthritis of Knee 
Scientific Title of Study   To Determine the effect of selective Acupuncture points among the individuals with Osteoarthritis of knee -A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V Ashtalakshmi 
Designation  PG Scholar 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block, Ground floor, Kamarajar nagar,Chengalpattu

Kancheepuram
TAMIL NADU
603001
India 
Phone  9940026981  
Fax    
Email  drashtabnys@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr N Prabu 
Designation  Assistant Medical Officer/ Lecturer Grade II 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block, Ground floor, Kamarajar nagar,Chengalpattu

Kancheepuram
TAMIL NADU
603001
India 
Phone  9566351891  
Fax    
Email  drprabubnys91@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr N Prabu 
Designation  Assistant Medical Officer/ Lecturer Grade II 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block, Ground floor, Kamarajar nagar,Chengalpattu

Kancheepuram
TAMIL NADU
603001
India 
Phone  9566351891  
Fax    
Email  drprabubnys91@gmail.com  
 
Source of Monetary or Material Support  
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Kamaraja Nagar, Chengalpattu 603001, Tamil Nadu, India 
 
Primary Sponsor  
Name  Dr V Ashtalakshmi 
Address  184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block, ground floor, Kamarajar nagar, Chengalpattu 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr V Ashtalakshmi  International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu  184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block, ground floor, Kamarajar nagar, Chengalpattu
Kancheepuram
TAMIL NADU 		 9940026981

drashtabnys@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu-603001  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Acupuncture  Patient undergoes needling on selective acupoints EX-LE-2, EX-LE-5, GB34, GV20, GB-31 for 20 minutes trice a week for 5 weeks 
Comparator Agent  Sham Acupuncture  Patient will undergo sham acupuncture for 20 minutes trice a week for 5 weeks 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Both male and female patients of age group 50 to 65 years already diagnosed with osteoarthritis of knee for more than 6 months and willing to give consent for study are included. 
 
ExclusionCriteria 
Details  people with other types of arthritis, congenital deformities, hairline fractures and fractures of knee. Patient with needle phobia and mentally unstable are excluded for the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of WOMAC (Western Ontario and Mcmaster universities Arthritis osteoarthritis index) scale   Baseline and 5 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Range of Motion of knee with Goniometer Scale  Baseline and 5 weeks 
 
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)   23/04/2025 
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="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Online

  6. For how long will this data be available start date provided 05-06-2024 and end date provided 06-07-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Osteoarthritis is a chronic degenerative disorder of multifactorial aetiology characterized by the loss of articular cartilage, hypertrophy of bone at the margins, subchondral sclerosis, and range of biochemical changes and morphological alterations of the synovial membrane and joint capsule. Worldwide about 10–15% of all adults aged over 60 have some degree of osteoarthritis. While the global prevalence of knee & hip osteoarthritis was 3.8% and 0.85% respectively. India’s elderly population (>60 yrs) is set to increase drastically from around 7.4% in 2001 to around 19% in 2050. Several studies have suggested the potential benefits of acupuncture to generally improve symptoms such as joint pain, swelling and stiffness in osteoarthritis of knee. A Randomized controlled trial will be adopted for this study. The simple randomization method with 1:1 ratio will be done for 60 subjects get a sample size of (n=30) in each group. After obtaining informed consent, participants who fit the inclusion criteria will be randomly allocated into GROUP A (study group) GROUP B (control group). GROUP A will receive selective Acupuncture points at GB-31(FENGSHI), GB-34(YANGLINGQUAN), GV-20(BAIHUI), EX-LE-2(HEDING), EX-LE-5 (MEDIAL XIYAN & LATERAL XIYAN), to the affected knee for 20 minutes, three days per week and for 5 weeks. While the GROUP B (control group) will receive sham acupuncture for 20 minutes to the affected knee, thrice a week for 5 weeks. As a primary assessment WOMAC Scale is used to measure the difficulties in daily activities of the osteoarthritis patients at baseline and 5th week. As a Secondary outcome the range of motion of knees will be measured using the Goniometer on baseline and at 5th week. 
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