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CTRI Number  CTRI/2026/03/106317 [Registered on: 16/03/2026] Trial Registered Prospectively
Last Modified On: 13/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical study on effect of Viddhakarma Therapy in management of Episcleritis (Sirotpat) 
Scientific Title of Study   Single-arm clinical study to evaluate the efficacy of Viddhakarma in the management of Sirotpat with special reference to Episcleritis 
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 Sanika Prabhakar Khokle  
Designation  MS Scholar Shalakyatantra (Ayurveda) 
Affiliation  MAMS Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD NO.9 Department of Shalakyatantra ,Sane Guruji Arogya Kendra,Malwadi Road Hadapsar,Pune MAHARASHTRA 411028 INDIA

Pune
MAHARASHTRA
411028
India 
Phone  9822476626  
Fax    
Email  725khokalesanika@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Sumedha Kotangale  
Designation  HOD Shalakyatantra  
Affiliation  MAMS Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD NO.9 Department of Shalakyatantra ,Sane Guruji Arogya Kendra,Malwadi Road Hadapsar,Pune MAHARASHTRA 411028

Pune
MAHARASHTRA
411028
India 
Phone  8275298480  
Fax    
Email  sumedhayk@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Sumedha Kotangale  
Designation  HOD Shalakyatantra  
Affiliation  MAMS Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD NO.9 Department of Shalakyatantra ,Sane Guruji Arogya Kendra,Malwadi Road Hadapsar,Pune MAHARASHTRA 411028

Pune
MAHARASHTRA
411028
India 
Phone  8275298480  
Fax    
Email  sumedhayk@yahoo.com  
 
Source of Monetary or Material Support  
Department of Shalakyatantra, Sane Guruji Arogya Kendra Malwadi, Hadpsar ,Pune MAHARASHTRA 411028 INDIA 
 
Primary Sponsor  
Name  Sane Guruji Arogya Kendra 
Address  OPD NO.9 Department of Shalakyatantra ,Sane Guruji Arogya Kendra,Malwadi Road Hadapsar,Pune MAHARASHTRA 411028 INDIA 
Type of Sponsor  Research institution and hospital 
 
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 Sanika Prabhakar Khokle  MAMs Sumatibhai Shah Ayurved Mahavidyalaya  OPD No 9, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra 411028
Pune
MAHARASHTRA 
9822476626

725khokalesanika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAMs SSAM and Sane Guruji Arogya Kendra Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H151||Episcleritis. Ayurveda Condition: SIROTPATAH/SIROTPATA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vedhana-karma, वेधन-कर्म (Procedure Reference: Not Applicable, Procedure details: 1. Clean area near affected eye with spirit soaked cotton. 2. Patient is asked to close eyes. 3. Using 26 G half inch needle perform Viddha holding needle at right angle, pricking & immediately withdrawing the needle. 4. Viddhakarma is performed at Upanasika, Apanga & Lalat.)
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1]Patients satisfying following classical symptoms
a. Vedana (pain)
b. Raktrajit shukla(congestion)
c. Dah/Ushyate(burning sensation)
d. Ashof-ashru-updeha(No swelling, discharge)
2]Age group: 19-60 years
3]Irrespective of gender 
 
ExclusionCriteria 
Details  1]Patients with corneal injury,corneal ulcer or iridocyclitis
2]Patients with malignancies or contagious diseases
3]Patients with known bleeding disorders
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in symptoms such as Vedana (pain), Raktrajit shukla(congestion), Dah/Ushyate(burning sensation), Ashof-ashru-updeha(No swelling, discharge)  Follow up on 2nd and 5th day. Symptoms will be noted. Observational follow up on 7th day. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   15/04/2026 
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="15" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Episcleritis is a common inflammatory condition of the episclera characterized by redness, mild ocular discomfort, and localized congestion of the eye. In Ayurveda, a similar clinical presentation is described as Sirotpat, which is classified under Sarvagata Netra Roga by Acharya Sushruta and Shuklagata Roga by Acharya Vagbhata. Modern management of episcleritis mainly involves topical non-steroidal anti-inflammatory drugs and corticosteroids, which may provide symptomatic relief but can cause adverse effects with prolonged use. Therefore, exploring effective and safe alternative therapies is essential.

Viddhakarma, an Ayurvedic para-surgical procedure involving controlled pricking at specific points using a sterile needle, is described for relieving vitiated Doshas and reducing pain and congestion. This study aims to evaluate the efficacy of Viddhakarma in the management of Sirotpat with special reference to episcleritis.

A single-arm clinical study will be conducted on patients diagnosed with episcleritis. Participants fulfilling the inclusion criteria will undergo Viddhakarma therapy, and clinical parameters such as redness, pain, burning sensation, and congestion will be assessed before and after treatment. The outcomes will be evaluated using appropriate clinical grading and statistical analysis.

The study is expected to provide evidence regarding the therapeutic potential of Viddhakarma as a safe, cost-effective, and minimally invasive treatment modality for episcleritis.
 
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