| CTRI Number |
CTRI/2026/02/104039 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
14/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Yastimadhu Triphala Vati in Simple Allergic Conjunctivitis |
|
Scientific Title of Study
|
Efficacy Of Yashtimadhu Triphala Vati as a Prebiotic On Occular
Microbiota in Simple Allergic Conjunctivitis: An Exploratory Study |
| 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 Swarali Gangshettiwar |
| Designation |
PG Scholar Shalakyatantra |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre Pune |
| Address |
OPD NO 6 Department of Shalakyatantra Dr. D. Y. Patil College of Ayurved and Research Centre
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8379092182 |
| Fax |
|
| Email |
swaralisgangshettiwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Jagtap |
| Designation |
M.S. PhD. Shalakyatantra |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre Pune |
| Address |
OPD NO 6 Department of Shalakyatantra Dr. D. Y. Patil College of Ayurved and Research Centre
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8983535924 |
| Fax |
|
| Email |
pallavibhor78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swarali Gangshettiwar |
| Designation |
PG Scholar Shalakyatantra |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre Pune |
| Address |
OPD NO 6 Department of Shalakyatantra Dr. D. Y. Patil College of Ayurved and Research Centre
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8379092182 |
| Fax |
|
| Email |
swaralisgangshettiwar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
Opd no 6 Department of shalakyatantra Dr D Y Patil College of Ayurved and Research Centre |
| Type of Sponsor |
Other [(self)] |
|
|
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 Swarali Sunil Gangshettiwar |
Dr. D. Y. Patil Ayurved Hospital and Research Centre, Pimpri, Pune |
OPD No. 6 Department of Shalakyatantra, Dr. D. Y. Patil Ayurved Hospital and Research Centre, Pimpri, Pune 411018, Maharashtra, India
Pune
MAHARASHTRA |
8379092182
swaralisgangshettiwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. DYPCA and RC INSTITUTIONAL ETHICS COMMITTEE, PIMPRI, PUNE - 18. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H101||Acute atopic conjunctivitis. Ayurveda Condition: ABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Yashtimadhu Triphala Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with minimum 3 of the total symptoms of Simple Allergic Conjunctivitis i.e
Pricking Pain, Watering of eyes, and Foreign body sensation, Dryness, Presence of Papillae, Congestion of Conjunctiva will be selected
Between the age group of 18 to 60 yrs. will be included in the study.
Irrespective of daily routine and diet patients will be selected |
|
| ExclusionCriteria |
| Details |
Patients with any other ocular pathology like Bacterial conjunctivitis, corneal opacity, corneal ulcer, Malignancy, dacryocystitis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in total viable count of microorganisms in conjunctival swabs after treatment with Yashtimadhu Triphala Vati. |
30 days with assessment on 0th day and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in signs and symptoms of allergic conjunctivitis such as:
Pricking Pain, Watering of eyes, Foreign body sensation, Presence of Papillae, Congestion of Conjunctiva, Feeling of
Dryness |
30 days with assessment on 0th day and 30th day |
|
|
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)
|
09/03/2026 |
| 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="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
|
This study aims to study the efficacy of Yashtimadhu Triphala Vati as a prebiotic on ocular microbiota on 30 patients suffering from Simple Allergic Conjunctivitis. 1gm vati will be administered twice a day for the duration of 30 days assessment will be done on 0th and 30th day. final conclusion will be drawn on the basis of statistical analysis. |