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CTRI Number  CTRI/2024/05/067206 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 13/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic management for Carpal Tunnel Syndrome - A randomized pilot clinical trial.  
Scientific Title of Study   A comparative analysis of Agnikarma and Siravyadha in the management of Carpal Tunnel Syndrome - – A randomized pilot clinical trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pratap Shankar K M 
Designation  Research Officer (Ay.) 
Affiliation  National Ayurveda Research Institute for Panchakarma 
Address  Room no. 621, Department of Ayurveda, National Ayurveda Research Institute for Panchakarma

Thrissur
KERALA
679531
India 
Phone  9744824014  
Fax    
Email  kmpvarma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pratap Shankar K M 
Designation  Research Officer (Ay.) 
Affiliation  National Ayurveda Research Institute for Panchakarma 
Address  Room no. 621, Department of Ayurveda, National Ayurveda Research Institute for Panchakarma


KERALA
679531
India 
Phone  9744824014  
Fax    
Email  kmpvarma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pratap Shankar K M 
Designation  Research Officer (Ay.) 
Affiliation  National Ayurveda Research Institute for Panchakarma 
Address  Room no. 621, Department of Ayurveda, National Ayurveda Research Institute for Panchakarma


KERALA
679531
India 
Phone  9744824014  
Fax    
Email  kmpvarma@gmail.com  
 
Source of Monetary or Material Support  
National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur, Kerala - 679531, India 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Janakpuri, New Delhi 110058 (India) 
Type of Sponsor  Research institution 
 
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 
Pratap Shankar K M  National Ayurveda Research Institute for Panchakarma  Room no. 621, Department of Ayurveda, Cheruthuruthy
Thrissur
KERALA 		 9744824014

kmpvarma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Ayurveda Research Institute for Panchakarma  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G560||Carpal tunnel syndrome. Ayurveda Condition: SNAYUGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Susrutha Samhita Chikitsa Sthana 1/8, Procedure details: Agnikarma (with Pancha lohasalaka) over the plantar aspect of the wrist of the affected hand. Bindu type of agnikarma will be done from the radial border to the ulnar border, extending one finger above & below the wrist crease. Two sittings with an interval of 15 days)
2Comparator ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: Astanga Hrdayam Sutra Sthanam 27/16, Procedure details: Sirvyadana – vein near the cubital fossa (cephalic vein) will be punctured. Two sittings with an interval of 15 days Volume – 40 to 60 ml)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Clinically diagnosed mild to moderate CTS and confirmed through NCS 
 
ExclusionCriteria 
Details  1. Patients with uncontrolled diabetes, hypothyroidism and rheumatoid arthritis.
2. Pregnant ladies
3. Patients previously operated for CTS
4. Patients with other types of neuropathies, inflammatory arthritis, soft tissue rheumatism, post trauma or wrist surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in symptom severity and functional severity scale score (BCTQ)   1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Phalen’s maneuver test and Tinel’s sign  1 month 
 
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 4 
Date of First Enrollment (India)   22/05/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kmpvarma@gmail.com].

  6. For how long will this data be available start date provided 01-04-2025 and end date provided 01-04-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

To compare the effectiveness of Agnikarma and Siravyadha in reducing CTS symptoms and improving functional status in patients with mild-to-moderate CTS.

 
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