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CTRI Number  CTRI/2024/06/068462 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 05/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of KECTS (Knee Expert Clinic Treatment Strategy) on Knee osteoarthritis 
Scientific Title of Study   Single arm Pilot study to test the efficacy of KECTS in advanced knee osteoarthritis. 
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 Kalpana Gholap 
Designation  Professor 
Affiliation  Dr G D Pol Foundation Y M T Ayurvedic Medical College and Hospital 
Address  Panchkarma Departmental OPD and IPD Dr G D Pol Foundation Y M T Ayurvedic College Hospital and PG Institute Institutional Area Sector No 04 Kharghar

Raigarh
MAHARASHTRA
410210
India 
Phone  9833971482  
Fax  27749895  
Email  kalpu.gholap@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kalpana Gholap 
Designation  Professor 
Affiliation  Dr G D Pol Foundation Y M T Ayurvedic Medical College and Hospital 
Address  Panchkarma Departmental OPD and IPD Dr G D Pol Foundation Y M T Ayurvedic College Hospital and PG Institute Institutional Area Sector No 04 Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9833971482  
Fax  27749895  
Email  kalpu.gholap@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kalpana Gholap 
Designation  Professor 
Affiliation  Dr G D Pol Foundation Y M T Ayurvedic Medical College and Hospital 
Address  Dr G D Pol Foundation YMT Ayurvedic Medical College Hospital and PG Institute Institutional Area Sector No 04 Department-Panchkarma Ayurvedic section 1st floor Kharghar

Raigarh
MAHARASHTRA
410210
India 
Phone  9833971482  
Fax  27749895  
Email  kalpu.gholap@gmail.com  
 
Source of Monetary or Material Support  
TechClinic Connect Private Limited, Sanpada Head Office, 1201 G-Square Business Park, Sector-30A, Opposite Sanpada Railway Station, Sanpada, Navi Mumbai, Maharashtra, India 
 
Primary Sponsor  
Name  TECH CLINIC CONNECT PRIVATE LIMITED 
Address  TechClinic Connect Private Limited, Sanpada Head Office, 1201 G-Square Business Park, Sector-30A, Opposite Sanpada Railway Station, Sanpada, Navi Mumbai, Maharashtra, India 
Type of Sponsor  Private hospital/clinic 
 
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 Kalpana Gholap  Dr. G. D. Pol foundation Y.M.T. Ayurvedic Medical College and Hospital  Dr.G.D.Pol foundation Y.M.T.Ayurvedic Medical College and Hospital, Panchkarma Departmental OPD and IPD, Institutional Area, Sector No-04, Kharghar, Navi Mumbai-410210, Maharashtra, India
Raigarh
MAHARASHTRA 		 9833971482

kalpu.gholap@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
YMT Ayurvedic Medical college and charitable Hospital(Research Pg Institute)  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. Ayurveda Condition: ASTHIKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Erand-Shunti oil, Reference: NA, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: single dose on day 1 followed by 5 ml
(2) Medicine Name: Saatvik Shuddhi , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: single day
(3) Medicine Name: PRANAYU TABLET, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: from 5 th day onwards
(4) Medicine Name: ATULYA SHUDDHI TABLET, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: from 5 th day onwards
2Intervention ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: patrapottali and dhara, Procedure details: The Patra Pottali provided will be dipped in warm ErandShunti Oil (34℃- 37 ℃ ) and applied immediately to the knees in circular anti-clockwise motion for 10 minutes minimum which may be extended up to 30 minutes as per participant’s ability to endure heat over the)
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Primary complaint of Knee pain- Unilateral or Bilateral, accompanied
with Joint Space Narrowing OR cartilage loss and other associated
symptoms.
2. Grade 3 and Grade 4 on Kellgren Lawrence OA classification.
3. Chronic knee pain- lasting for more than 3 months with Joint space
narrowing at atleast one knee joint either medial/ lateral or both.
4. Willing to complete all study procedures including study-related
questionnaires and comply with study requirements.
5. Willing to abstain from other supplements or medication.
6. Ready to give voluntary, written, informed consent to participate in the study. 
 
ExclusionCriteria 
Details  1. Acute Knee pain due to Traumatic injury with fracture or ligament
tear.
2. Persons diagnosed with Rheumatic arthritis, Polyarteritis Nodosa,
Gout, Fibromyalgia, Scleroderma.
3. Persons with auto-immune disorders.
4. Persons with BMI greater than 34.9.
5. Persons diagnosed with AIDS, Hepatitis B, patients on ART.
6. Persons with congenital joint disorders.
7. Persons who are diagnosed with Pulmonary or extra pulmonary
Tuberculosis, pleural effusion, COPD, Bronchial asthma, or severely
compromised lung function.
8. Diagnosed with Hansen’s disease or any other infectious disease that
needs immediate and long-duration treatment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the impact of KECTS on minimum Joint Space Width (mJSW) in persons with knee pain and Joint space narrowing with the help of Radiographs  Day 1,21,42,60 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the impact of the KECTS on Pain using assessment of
NPRS.
2. To assess the impact of KECTS on functionality of the knee joint
using KOOS (Knee Injury and Osteoarthritis Outcome) scale. 		 1. To assess the change in NPRS from Day 1 of Stage 1 to DAY 60 of
Stage 2.
2. To assess the change in functionality using KOOS scale from Day 1 of
Stage 1 to DAY 60 of Stage 2. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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/ Phase 4 
Date of First Enrollment (India)   17/06/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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

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

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (not yet).

  6. For how long will this data be available start date provided 01-09-2024 and end date provided 30-09-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
The present study is the clinical study for osteoarthritis under sponsorship of TechClinic Connect Pvt. Ltd.,

Study type:-Open labelled single arm un-controlled study to test the efficacy of KECTS

Total - 20 patients

Duration - 3 months

Study center:- Dr. G. D. Pol Foundation YMT Ayurvedic Medical College and Hospital, Kharghar 

Purpose of Study - Many patients having Knee pain associated with Joint space narrowing. Joint space narrowing occurs due to cartilage degeneration, wear and tear causing pain in the knees. The above cases gets cured by surgical interventions or injections at the site in modern practices but instead that we are offering treatment using herbo-mineral products orally and some external Panchkarma procedures locally at the site of knee


 
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