| CTRI Number |
CTRI/2025/12/098695 [Registered on: 09/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate efficacy of saindhavadi siddha dugdha ashchyotan in vataj abhishyanda (simple allergic conjuctivitis) |
|
Scientific Title of Study
|
An open randomized control clinical trial of saindhavadi siddha dugdha ashchyotan in management of vataj abhishyanda with special reference to simple allergic conjuctivitis |
| 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 Pranjal Arun Salve |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
Department of Shalakyatantra of Dhanvantari hospital of hon. shri Annasaheb Dange Ayurved Medical College , Ashta Tal-Walwa Dist- Sangli
Department of Shalakyatantra of dhanvantari hospital of Hon Shri Annasaheb Dange Ayurved Medical College , Ashta Tal-Walwa Dist- Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
7875444603 |
| Fax |
|
| Email |
prnjlslv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pournima Vilas Fasale |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
Department of Shalakyatantra of dhanvantari hospital of Hon Shri Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist- Sangli
Department of Shalakyatantra of dhanvantari hospital of Hon Shri Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist- Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9970177583 |
| Fax |
|
| Email |
pournimafasale33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr pournima Vilas Fasale |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
Department of Shalakyatantra of dhanvantari hospital of Hon Shri Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist- Sangli
Department of Shalakyatantra of dhanvantari hospital of Hon Shri Annasaheb Dange Ayurved Medical College , Ashta Tal-Walwa Dist- Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9970177583 |
| Fax |
|
| Email |
pournimafasale33@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pranjal Arun Salve |
| Address |
Department of Shalakyatantra of dhanvantari hospital of Hon Shri Annasaheb Dange ayurved medical College ashta tal.walwa dist.sangli |
| 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 Pranjal Salve |
Dhanvantari Rugnalaya Ashta |
Opd no. 2 Netra roga OPD ground floor
Sangli
MAHARASHTRA |
7875444603
prnjlslv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon.shri annasaheb dange institutional ethical commitee |
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 | Comparator Arm | Procedure | - | AScyotanam, आश्च्योतनम् | (Procedure Reference: SHARANGDHAR, Procedure details: Keep the patient in lying down, relaxed position.
With left hand open the left eye of the patient.
With the help of Pichu or Varti, instil the medicated drops at the inner canthus from the distance of 2 angulas.
Depending upon Dosha, & disease determine the dose of drug & retaining time.
Extra liquid should be soaked with clean & soft cloth.)
| | 2 | Intervention Arm | Procedure | - | AScyotanam, आश्च्योतनम् | (Procedure Reference: sharangdhar, Procedure details: Keep the patient in lying down, relaxed position.
With left hand open the left eye of the patient.
With the help of Pichu or Varti, instil the medicated drops at the inner canthus from the distance of 2 angulas.Depending upon Dosha, & disease determine the dose of drug & retaining time.
Extra liquid should be soaked with clean & soft cloth.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient show symptoms of allergic conjuctivitis
2)Patient with age above 18 years
3)Patient irrespective of gender , educational socioeconomic ,marital and caste status |
|
| ExclusionCriteria |
| Details |
1)Any other active acute infective ocular diseases
2)Recently operated eye within 1 month
3)Patient having systemic disease like DM,CA |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Redness of eyes,watery mucus, stringy discharge, burning sensation , oedema of eyelids , photophobia , intence itching will be decreased and relief from simple allergic conjuctivitis . |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study adverse effect of sandhavadi siddha dugdha aschotan in vataj abhishyanda with special reference to simple allergic conjuctivitis |
15 days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
20/12/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [prnjlslv@gmail.com].
- For how long will this data be available start date provided 23-08-2024 and end date provided 23-02-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Vataj abhishyanda can be corelated with simple allergic conjuctivitis. In modern science practices there is a symptomatic treatment for vataj abhishyanda that is simple allergic conjuctivitis includes antibiotic eye drops followed by antibiotics and analgesics where as in ayurveda there are many formulations like anjana ashchyotan bidalaka with internal medications has been explained various drugs for vataj abhishyanda have been explored scientifically saindhavadi siddha dugdha was not studied yet hence hoping this study contributes further to public health i have decided to use saindhavadi siddha dugdha ashchyotan in management of vataj abhishyanda reffered from sushrut samhita. |