| CTRI Number |
CTRI/2025/12/099897 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on the Role of Ayurvedic Eye Therapy (Akshitarpana with Jivaniya Ghrita) in Managing Dry Eye Syndrome |
|
Scientific Title of Study
|
An Open-Label Randomised Controlled Clinical Trial on Role of Akshitarpana Kriya Kalpa with Jivaniya Ghrita in the management of Shushkakshipaka w.s.r. to Dry Eye Syndrome. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ProfVijay Chaudhary |
| Designation |
Principal cum Dean |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola H.P. |
| Address |
Principal office,Admin block,
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfVijay Chaudhary |
| Designation |
Principal cum Dean |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola H.P. |
| Address |
Principal office,Admin block,
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naveen Shandil |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola H.P. |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
6230280288 |
| Fax |
|
| Email |
naveenshandil80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola H.P. |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola H.P. |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt. Kangra H.P. 176115,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 |
| Prof Vijay Chaudhary |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola H.P. |
OPD No 219, Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola H.P. Pin code 176115
Kangra
HIMACHAL PRADESH |
09418130228
drvijaychaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human) Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P. 176115 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H048||Other disorders of lacrimal system. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | netratarpaNam, नेत्रतर्पणम् | (Procedure Reference: Sushruta uttartantra-9/21, Procedure details: Purva Karma-Sthanik Abhyanga and Mridu Swedana
Pardhana Kamra-
Patient lies in supine position, face upwards.
Room should be devoid of wind, sun, and dust.
A wall is constructed around the eye socket using Masa flour, resembling awell, Height: 2 fingers.
Jivaniya Ghrita (liquefied with hot water) is poured into the well up to the tips of eyelashes
Patient is instructed to open eyes slowly and retain the drug
Duration measured by 1000 Matra kaal (05 minutes)
Pashchata Karma-
After stipulated retention, Ghrita is drained through a hole at the bottom of the dough wall near the outer canthus.
The eye is irrigated with lukewarm water fomentation.
Stimulated Kapha is eliminated by Dhoompana)
(1) Medicine Name: Jivaniya Ghrit , Reference: Ashtanga Hrudya Uttartantra 16/28, Route: Ocular, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Carboxymethyl Cellulose (CMC) 0.5 percent weight by volume eye drops | 1 drop– 4 times a day for 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate in the trial.
Patients presenting with signs and symptoms of Shushkakshipaka / Dry Eye
Syndrome with at least 1 positive diagnostic test.
Patients above the age of 18 years will be selected.
Patient with no history of allergic reaction to Ghrita or any trial drug ingredient.
|
|
| ExclusionCriteria |
| Details |
Patients with systemic conditions like Diabetic Mellitus, Autoimmune disorders
affecting vision, Rheumatoid Arthritis.
Patients with severe eye disorders including Glaucoma, Cataract or active infections (Infective conjunctivitis /keratitis).
Disorders of lid globe apposition.
Pregnant and lactating women.
Patients not willing to be registered for the trial.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Akshitarpan with Jivaniya Ghrit in the management of Shushkakshipak. |
follow up at day 7, 15 and 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of Akshitarpan with Jivaniya Ghrit and CMC 0.5 % w/v eye drops in the management of Shushkakshipak.
To assess the clinical safety of Akshitarpan with Jivaniya Ghrit in patients of Shushkakshipak. |
follow up at day 7, 15 and 30 |
|
|
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 |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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="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
|
I would like to publish my research work after completion of the trial as soon as possible. Patients will be selected from OPD/IPD of RGGPG Ayurvedic College and Hospital,Paprola. 2 groups of 30 patients will be registered and assessed to evaluate the effect of Akshitarpana Kriya Kalpa with Jivaniya Ghrita in the management of Shushkakshipaka with special reference to Dry Eye Syndrome. |