| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H151||Episcleritis. Ayurveda Condition: SIROTPATAH/SIROTPATA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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. |