| CTRI Number |
CTRI/2025/02/080401 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to see the effect of ayurvedic formulation in the form of Local Application in the treatment of Vataja Abhishyanda with reference to Allergic Conjunctivitis |
|
Scientific Title of Study
|
A randomized controlled trial to study the efficacy of Pathyadi Bidalaka and Olopatadine eye drop in Vataja Abhishyanda with reference to Allergic Conjunctivitis |
| 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 Nirav Ashokbhai Sapariya |
| Designation |
MS Scholar Shalakyatantra (Ayurved) |
| Affiliation |
Mams Sumatibhai Shah Ayurved Mahavidhyalaya, Hadapsar, Pune |
| Address |
OPD NO 9 Department of Shalakyatantra ,Sane Guruji Arogya
Kendra Malwadi,Hadapsar Pune , MAHARASHTRA 411028 INDIA
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411028
India |
| Phone |
9834186761 |
| Fax |
|
| Email |
niravsapariya12051998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Mrs Nilakshi S Pradhan |
| Designation |
H.O.D. Shalakyatantra |
| Affiliation |
Mams Sumatibhai Shah Ayurved Mahavidhyalaya, Hadapsar, Pune |
| Address |
OPD NO 9 Department of Shalakyatantra ,Sane Guruji Arogya
Kendra Malwadi,Hadapsar Pune , MAHARASHTRA 411028 INDIA
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Mrs Nilakshi S Pradhan |
| Designation |
H.O.D. Shalakyatantra |
| Affiliation |
Mams Sumatibhai Shah Ayurved Mahavidhyalaya, Hadapsar, Pune |
| Address |
OPD NO 9 Department of Shalakyatantra ,Sane Guruji Arogya
Kendra Malwadi,Hadapsar Pune , MAHARASHTRA 411028 INDIA
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra, Sane Guruji Arogya Kendra Malwadi, Hadapsar, Pune 411028
Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
OPD NO.9, Department of Shalakyatantra, Sane Guruji Arogya
Kendra, Malwadi road Hadapsar, Pune MAHARASHTRA
411028,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 |
| Dr Nirav Ashokbhai Sapariya |
Sane Guruji Arogya kendra ,Malwadi road Hadapsar |
OPD NO.9 Department
of Shalakyatantra, Sane
Guruji Arogya kendra
Malwadi road,
Hadapsar, Pune
MAHARASHTRA
411028, India
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9834186761
niravsapariya12051998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 (Non Ayurveda) | | - | Olopatadine eye drop | Olopatadine 0.1% eye drop
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Vataja Abhishyanda with symptoms like Netra Toda (pricking sensation), Sangharsha (itching sensation), Shishirashruta (cold lacrimation), and Alpa shopha. |
|
| ExclusionCriteria |
| Details |
Patients with Pittaja, Kaphaja, Raktaja Abhishyanda lakshana.
Patients suffering with any other severe ocular infection like corneal ulceration.
Patients with any autoimmune disorder e.g., rheumatoid arthritis.
Pregnant women and children. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptoms like -
1)Nistodan (pricking sensation)
2)Sangharsha (itching sensation)
3)Shishirashruta (cold lacrimation)
4)Alpha Shopha (conjunctival edema)
Will be decreased and relief from Allergic Conjunctivitis |
Follow up on 4th and 7th day symptoms will be noted before and after the treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decrease in severity , duration of symptoms |
18 months |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
20/03/2025 |
| 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="15" |
|
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
|
Ayurveda is broadly classified into 8 parts called as Astang Ayurveda. Shalakya Tantra is one part of Astang Ayurveda which deals with the diseases of Urdhva-jatru i.e. body over the clavicle mainly it deals with the diseases of eyes, mouth, nose etc. To treat these diseases Shalaka (Probe) is used. So the subject is called as "Shalakya Tantra". Shalakyatantra is nothing but the branch that cures the diseases above clavicle i.e. eye, ear, nose, mouth and throat along with Shirorogas. Vataja Abhishyanda is one of the most common eye disorders that affect people of all age groups and can be correlated to Allergic Conjunctivitis based on their signs and symptoms. Abhishyanda (Conjunctivitis) is the root cause for most of the eye disorders and must be treated early with effective way possible or it might lead to severe complications and would be very difficult to save the eyesight. If Abhishyanda (Conjunctivitis) becomes chronic, it may lead to dreadful complications, making the disease unmanageable. In Modern medicine, this is managed with the administration of eye drops and anti-allergic medicines that are associated with some adverse effects. Ayurvedic management of Allergic conjunctivitis has shown some effective results in overcoming the ailment with no such effects and non-recurrence. Hence here an effort has been made to elucidate about Vataja abhishyanda and its management that is outlined in Ayurvedic classics. |