| CTRI Number |
CTRI/2026/04/108827 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| 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
|
A clinical study to assess the effect of Shadanga kwatha guggulu and Darvyadi rasakriya on eye allergy |
|
Scientific Title of Study
|
An Open-Label Randomized Pilot Clinical Trial to Evaluate the Efficacy of Shadanga Kwatha Guggulu and Darvyadi Rasakriya on Vernal Keratoconjunctivitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana K S |
| Designation |
Junior Resident |
| Affiliation |
Faculty Of Ayurveda, Banaras Hindu University |
| Address |
Department Of Shalakya Tantra
Faculty Of Ayurveda
Banaras Hindu University
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9072211710 |
| Fax |
|
| Email |
archanasanathanan001@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof. Manoj Kumar |
| Designation |
Professor and Head |
| Affiliation |
Faculty Of Ayurveda, Banaras Hindu University |
| Address |
Department Of Shalakya Tantra
Faculty Of Ayurveda
Banaras Hindu University
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9793127744 |
| Fax |
|
| Email |
mkumarbhu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Archana K S |
| Designation |
Junior Resident |
| Affiliation |
Faculty Of Ayurveda, Banaras Hindu University |
| Address |
Department Of Shalakya Tantra
Faculty Of Ayurveda
Banaras Hindu University
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9072211710 |
| Fax |
|
| Email |
archanasanathanan001@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
BANARAS HINDU UNIVERSITY |
| Address |
Faculty Of Ayurveda
Institute Of Medical Science
Banaras Hindu University
Varanasi |
| 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 |
| Archana K S |
Sir Sunderlal Hospital |
Department Of Shalakya tantra OPD 13
Faculty Of Ayurveda IMS BHU
Regional Institue Of Ophthalmology
IMS BHU Varanasi UTTAR PRADESH |
9072211710
archanasanathanan001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHU IMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H162||Keratoconjunctivitis. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | a~jjanam, अंजनम् | (Procedure Reference: Ashtanga Hridaya Sutrasthan, Procedure details: Darvyadi Rasakriya will be applied as Anjana 1 drop twice daily.
After 10 minutes prakshalana will be done with clean water) (1) Medicine Name: Darvyadi Rasakriya, Reference: Bhaishajyaratnavali , Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(drops), Frequency: bd, Duration: 6 Weeks | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shadangakwatha Guggulu , Reference: Bhaishajyaratnavali , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: Guggulu ), Additional Information: For children above 10 years of age 40 ml BID | | 3 | Comparator Arm (Non Ayurveda) | | - | Carboxy methyl cellulose 0.5 % eye drops | Carboxy methyl cellulose 0.5 % eye drops one drop 4 times daily |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with VKC
No treatment for VKC for at least 2 weeks prior to the enrolment
Willingness to comply with follow-up schedule
|
|
| ExclusionCriteria |
| Details |
Patients with any relevant ocular anomaly other than VKC (trauma, post-radiation keratitis, severe blepharitis, rosacea, corneal ulcer), abnormal eyelid anatomy, nasolacrimal drainage system abnormalities, active herpes keratitis or ocular infections, contact lens wear during study, recent use of corticosteroids (within one week), topical immunosuppressants (within 90 days), systemic immunosuppressants (within 90 days), recent vernal plaque scraping (within one month), ocular surgery (within 6 months), known hypersensitivity to trial drugs, or history of ocular varicella-zoster or vaccinia virus infection will be excluded. |
|
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Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The changes in the symptoms (itching, burning sensation, redness, tearing, photophobia, foreign body sensation) at 3 weeks and 6 weeks follow-up from the baseline. |
3 weeks and 6 weeks from the baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The changes in Bonini’s scores at 3 weeks and 6 weeks from baseline assessment. |
3 weeks and 6 weeks from baseline |
|
|
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)
|
11/06/2026 |
| 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="4" 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
|
Vernal Keratoconjunctivitis (VKC) is a chronic, recurrent bilateral allergic inflammation affecting 3 to 10 percentage of school age children in tropical and subtropical regions, characterized by intense itching, photophobia, and papillary formations. The disease poses significant challenges due to its chronic nature, seasonal exacerbations, and potential sight threatening complications including corneal scarring, keratoconus, and amblyopia. Current management relies heavily on corticosteroids, mast-cell stabilizers, and immunosuppressants, yet faces critical limitations. The most prominent challenge is steroid dependence and resistance, with prolonged use carrying substantial risks including cataract formation, glaucoma, and growth suppression in paediatric patients. Alternative agents like cyclosporine-A present challenges of high cost, complex administration, and potential systemic toxicity, while mast-cell stabilizers demonstrate limited efficacy in moderate to severe cases. The chronic recurrent nature necessitates long term therapy, yet most available options are unsuitable for extended use due to adverse effect profiles, creating an urgent need for safe, effective, and sustainable treatment alternatives. In Ayurvedic medicine, VKC correlates with Kapha-Pitta predominant Abhishyanda and Pilla Roga. Sadanga Kwatha Guggulu and Darvyadi Rasakriya are classical formulations specifically indicated for inflammatory ocular conditions including sopha, paka, akshishula, daha, and raga. These formulations possess documented anti-inflammatory, immunomodulatory, and antioxidant properties, with traditional texts indicating their suitability for long term use in chronic conditions. Despite centuries of empirical use, these formulations have not been evaluated through rigorous controlled trials for VKC management. This research investigates whether these classical Ayurvedic formulations can provide effective, safe therapeutic alternatives, potentially addressing critical gaps in current treatment paradigms and offering improved long-term management strategies for paediatric VKC patients without the limitations and complications associated with conventional pharmacotherapy. |