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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  
NIL 
 
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  
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 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H162||Keratoconjunctivitis. Ayurveda Condition: NETRAROGAH/AKSHIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-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
2Intervention ArmDrugClassical(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
3Comparator Arm (Non Ayurveda)-Carboxy methyl cellulose 0.5 % eye dropsCarboxy 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. 
 
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.

 
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