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CTRI Number  CTRI/2025/11/096947 [Registered on: 06/11/2025] Trial Registered Prospectively
Last Modified On: 05/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Comparison Of Heat therapy Given With Foxtail Millet Powder And Sand In Radiating Shoulder Joint Pain 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Kangu-Churna Pinda Sweda with Valuka Sweda in the management of Vishwachi 
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 Rudra Gosai 
Designation  PG scholar 
Affiliation  G J Patel Institute of Ayurvedic Studies and research  
Address  Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388121.

Anand
GUJARAT
388121
India 
Phone  9723356801  
Fax    
Email  rudra12gosai@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sheetal Tokle 
Designation  Associate professor 
Affiliation  G J Patel Institute of Ayurvedic Studies and research  
Address  Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388121.

Anand
GUJARAT
388121
India 
Phone  7383747673  
Fax    
Email  s.tokle1411@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rudra Gosai 
Designation  PG scholar 
Affiliation  G J Patel Institute of Ayurvedic Studies and research  
Address  Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388121.

Anand
GUJARAT
388121
India 
Phone  9723356801  
Fax    
Email  rudra12gosai@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Rudra Gosai 
Address  PG Scholar, Department Of Panchakarma, GJ Patel Institute of Ayurvedic studies and research, New Vallabh Vidyanagar B/h. GIDC, ADIT Campus, Anand-388121, Gujarat, India 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
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 Rudra Gosai  S G Patel Ayurveda Hospital And Maternity Home   Department of Panchakarma, OPD NO.15,S.G. Patel Ayurveda Hospital and Maternity home New Vallabh Vidyanagar Behind GIDC ADIT Campus,Anand-388121,Gujarat
Anand
GUJARAT 		 9723356801

rudra12gosai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
G. J. PATEL INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M501||Cervical disc disorder with radiculopathy. Ayurveda Condition: VISVACI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-piNDasvedaH, पिण्डस्वेदः (Procedure Reference: Yogamrutham, Procedure details: 2 pottalis are prepared each containing 250gms of kanguchoorna. The patient should be seated on the table. The hot pottali should be gently applied over the body (42-45 degree celsius).Just pressing the body with pottali should be done. Both pottalis are used alternatively after reheating to maintain uniform temperature throughout the procedure. Same pottali can be used for three days. It should be done for about 30-35 minutes )
(1) Medicine Name: Kanguchoorna, Reference: Ashtang hrudaya, Route: Topical, Dosage Form: Churna/ Powder, Dose: 500(g), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-Valuka Pottali Sweda (Procedure Reference: Ashtanga Hrudaya,Sutra sthana 13, Procedure details: 2 pottalis are prepared each containing 250gms of valuka.The patient should be seated on the table. The hot pottali should be gently applied over the body (42-45 degree Celsius).Just pressing the body with pottali should be done. Both pottalis are used alternatively after reheating to maintain uniform temperature throughout the procedure. Same pottali can be used for three days. It should be done for about 30-35 minutes ))
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient full filling diagnostic criteria of Vishwachi
Participants who are indicated for Sweda karma 
 
ExclusionCriteria 
Details  participant not fit for Sweda as per ayurveda classics
Pregnant and lactating women
Patient with any history of fracture related to cervical joints. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Improvement in range of motion by goniometer of neck and shoulder
2. VAS score. 		 0 day,8th day,14th day 
 
Secondary Outcome  
Outcome  TimePoints 
Anorexia (Aruchi)
Lethargy (Tandra)
Heaviness in body (Gaurava) 		 0 day,8th day,14th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/12/2025 
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="6"
Days="0" 
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 - NO
Brief Summary  

The proposed study titled “A comparative clinical study to evaluate the efficacy of Kangu-Churna Pinda Sweda with Valuka Sweda in the management of Vishwachi” aims to scientifically assess two Ayurvedic Swedana therapies in the treatment of Vishwachi, a condition correlated with Cervical Radiculopathy. Vishwachi, described by Acharya Sushruta under Vata Vyadhi, presents with radiating neck pain, stiffness, tingling, and restricted movement of the upper limb. With modern sedentary habits, prolonged gadget use, and poor posture, cervical disorders have become increasingly common, while conventional management through analgesics, muscle relaxants, or surgery offers only temporary relief and potential complications.

This randomized controlled clinical trial will include 30 patients diagnosed with Vishwachi, divided into two groups. Group A will receive Valuka Sweda (sand fomentation) and Group B will receive Kangu Churna Pinda Sweda (fo mentation with roasted Kangu powder) for 7 days, applied for 35 minutes daily. Subjective parameters like pain, stiffness, tingling, and movement restriction, along with objective range of motion measurements, will be evaluated before and after treatment.

The study seeks to validate Kangu Churna Pinda Sweda as a more effective and holistic alternative to Valuka Sweda, offering sustainable symptom relief without adverse effects, thus contributing evidence-based support to traditional Ayurvedic management of Vishwachi.

 
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