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CTRI Number  CTRI/2025/04/085114 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 11/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative clinical study to evaluate the efficacy of Vyoshadhya gutika Koladi lepa and Trisneh tail in the management of Sandhigata vata w.s.r. Osteoarthritis 
Scientific Title of Study   A comparative clinical study of Vyoshadhya Gutika Koladi Lepa and Trisneh Tail in the management of santhigata Vata w.s.r. to Osteoarthritis 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchi Tirkey 
Designation  PG Scholar Department of Kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 
Address  OPD N0. 2 and 18 Department of Kayachikitsa, Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 India

Raipur
CHHATTISGARH
492010
India 
Phone  7987037224  
Fax    
Email  ruchitirkey24011991@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aruna Ojha 
Designation  Proffesor in Department of kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 
Address  OPD No. 2 and 18 Department of kayachikitsa, shri Narayna Prasad Awasthi Govt. Ayurved College, Raipur Chhatisgarh 492010 India

Raipur
CHHATTISGARH
492010
India 
Phone  9424401858  
Fax    
Email  arunaojha90@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arunima verma 
Designation  Reader in Department of Kayachikitsa  
Affiliation  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 
Address  OPD No. 2 and 18 Department of Kayachikitsa Shri Narayna Prasad Awasthi Government Ayurved college Raipur Chhattisgarh 492010 India

Raipur
CHHATTISGARH
492010
India 
Phone  9907424440  
Fax    
Email  arunima.ayu@gmail.com  
 
Source of Monetary or Material Support  
Department of kayachikitsa shri narayan prasad awasthi govt ayurveda college Raipur chhattisgarh 492010 
 
Primary Sponsor  
Name  Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur C.G 
Address  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh Pin 492010 India 
Type of Sponsor  Other [Government Ayurveda College Raipur Chhattisgarh ] 
 
Details of Secondary Sponsor  
Name  Address 
Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur CG  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh Pin 492010 India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ruchi Tirkey  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur   opd no2 and 18 ipd in the department of kayachikitsa at shri Narayan Prasad Awasthi Government Ayurveda College Raipur CHHATISGARH 492010
Raipur
CHHATTISGARH 
7987037224

ruchitirkey24011991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE GOVERNMENT AYURVED COLLEGE RAIPUR (C.G.) 492010  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: SANDHIGATAVATAH, (2) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, (3) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, (4) ICD-10 Condition:M199||Osteoarthritis, unspecified site. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vyoshadhya Gutika, Reference: Gadanigraha Khanda 1, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 650(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Sukhoshna jala), Additional Information: -
2Comparator ArmProcedure-lepa, लेप (Procedure Reference: Charak Samhita , Procedure details: By taking Koladi Lepa in powder form & applied it after mixing with mild hot Kanji. Duration - 1 time in a day for 1-2 hours)
(1) Medicine Name: Koladi Lepa, Reference: Charak Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 20(g), Frequency: od, Duration: 60 Days
3Comparator ArmProcedure-jAnu-bastiH, जानु-बस्तिः (Procedure Reference: Abhinava Chintamani, Procedure details: During this procedure creating a reservoir around the knee joint using dough made from Black gram flour then pour warm medicated oil which is Trisneh Tail into the reservoir, it nourishes the knee joint & resolves the disease called Sandhivata. Duration - 1 time in a day for 30-45 min. )
(1) Medicine Name: Koladi Lepa, Reference: Charaka Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 20(g), Frequency: od, Duration: 60 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  It based on clinical signs and symptoms mentioned in ayurveda classics and modern literature, especially Joint pain, morning stiffness in joints, swelling in joints with the help of Scoring vas scale visual analog scale WOMAC index 
 
ExclusionCriteria 
Details  1. Patients below 30 years and above 70 years of age will not be taken.
2. Patients diagnosed with Serious heart disease.
3. Blood related disorders.
4. Skin cancer.
5. Acute stage of diabetes.
6. Emergency fracture in the affected joint.
7. Pregnant and lactating women.
8. History of hypersensitivity to any of the trials and their ingredients.
9. Patients with serious kidney related problems.
10. Obese patients and if there is any kind of infection in the joint.




 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduce the symptom of sandhigata vata especially pain ,swelling,and stiffness(sandhigata vata)  reduce the symptom of sandhigata vata 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
improve the quality of life  90 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   Phase 3 
Date of First Enrollment (India)   11/05/2025 
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="0"
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 - NO
Brief Summary  
: According to acharya charak vata dosha increases, due to quality vata dries up the When the its rough shlesak kafa present in the Joint, due to which the normal functioning of the Joints is affected for reason. the this Sandigata vata diseases Caused by vata.
 they can be classified under the following headings. pratyatma lakshana. Sandh Sandhi Shoola, Sandhi shotha, prasarna  Akunchna vedna and stabdhata. the similarity of sandhigata vata is with Osteoarthritis described in morden  medical science
Osteoarthritis is a degenerative Joint dise ase in which the tissues in
the most common the joint break down
 Primary symptoms of OA are joint inflammation, pain, loss of function, and  pain during flexion extension of knee joint. For the present study, on SANDHIGATA VATA as shaman therapy, the medicine I choose is a suitable natural product that will make it possible for patients to live a high quality of life along with reducing the specific symptoms of pain, swelling & stiffness. These medicines have properties of deepan.pachan,
shoolahar & shothahar without any side effects in our textes. Considering the magnitude of sandhigata vata , I am doing a clinical & comparative study of vyoshadhya gutika  koladi  lepa and Trisneh tail  in the management of sandhigata vata
the volunteers will be informed about the study protocol, willing participants will be randomly selected as per the coin method. clinical research format will be prepared and validated before the study approval will be taken from the IEC of the NPA government Ayurved college and hospital, Raipur C.G.and CTRI registration will be done, after selection, each participant will be tasted individually and selected according to the selection criteria
 Sixty patients of sandhigata vata will be selected from Kayachikitsa OPD and IPD Shri NPA government Ayurveda college and hospital, Raipur C.G. The case selection was in regards to age, sex, occupation, and socioeconomic conditions. Both acute and chronic phases of sandhigata vata patients were taken for the study, following the CCRS criteria for diagnosing OA in modern medicine and the clinical features of sandhigata vata described in charka samhita . The present study is a single-center, open-labeled randomized (coin method) clinical trial. A total of 60 clinically diagnosed and registered patients of sandhigata vata were divided randomly by coin method into two groups. Each group will have 30 patients. Group A: 30 clinically diagnosed patients of sandhigata vata will be treated with vyoshadhya gutika two tablets(each 650 mg) three times in a day with lukewarm water before meal for 90 days along with koladi lepa every single day one time in a day with the help of kanji  Group B: 30 clinically diagnosed patients of sandhigata vata were treated with vyoshadhya gutika two tablet (each650mg) three times in a day with lukewarm water befor  meal for 90days along with Trisneh tail for janu vasti as per requirement for 10days after that I will give tail for abyangarth .
 Sixty patients of sandhigata vata will be selected from Kayachikitsa OPD and IPD Shrihri NPA government Ayurved college and hospital, Raipur C.G. The case selection was in regards to age, sex, occupation, and socioeconomic conditions. Both acute and chronic phases of sandhigata vata patients were taken for the study, following the CCRS criteria for diagnosing OA in modern medicine and the clinical features of sandhigata vata described in charka samhita . The present study is a single-center, open-labeled randomized (coin method) clinical trial. A total of 60 clinically diagnosed and registered patients of sandhigata vata were divided randomly by coin method into two groups. Each group will have 30 patients. Group A: 30 clinically diagnosed patients of sandhigata vata will be treated with vyoshadhya gutika two tablets(each 650 mg) three times in a day with lukewarm water before meal for 90 days along with koladi lepa every single day one time in a day with the help of kanji  Group B: 30 clinically diagnosed patients of sandhigata vata were treated with vyoshadhya gutika two tablet (each650mg) three times in a day with lukewarm water befor  meal for 90days along with Trisneh tail for janu vasti as per requirement for 10days after that I will give tail for abyangarth .
 
 
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