| CTRI Number |
CTRI/2025/08/092571 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Gruta Bhrusta Shabarak Lodhra Bidalak on Vataj Abhishyand |
|
Scientific Title of Study
|
ASSESSMENT OF EFFICIENCY OF GHRUTA BHRUSTA SHABARAK LODHRA BIDALAKA IN VATAJ ABHISHYANDA RANDOMISED CONTROLLED TRIAL |
| 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 Rajani Suresh Navale |
| Designation |
PG Scholar |
| Affiliation |
PMTs Ayurved College, Shevgaon |
| Address |
OPD NO.102 SHALAKYA TANTRA DEPARTMENT, SHRI EKNATH AYURVED RUGNALAYA, PMTs Ayurveda College, Shevgaon Akhegaon road, Tal.Shevgaon ,Dist . Ahemadnagar, Maharashtra
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
7798490388 |
| Fax |
|
| Email |
rajaninavale92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Dolas |
| Designation |
Asso Professor |
| Affiliation |
PMTs Ayurveda College, Shevgaon |
| Address |
OPD No.102 SHALAKYA TANTRA DEPARTMENT, SHRI EKNATH AYURVED RUGNALAYA,PMTs Ayurveda College, Shevgaon Akhegaon road, Tal.Shevgaon,Dist.Ahmadnagar, Maharashtra
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
8550991815 |
| Fax |
|
| Email |
maheshdolas23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Dolas |
| Designation |
Asso Professor |
| Affiliation |
PMTs Ayurveda College, Shevgaon |
| Address |
OPD No.102 SHALAKYA TANTRA DEPARTMENT, SHRI EKNATH AYURVED RUGNALAYA,PMTs Ayurveda College, Shevgaon Akhegaon road, Tal.Shevgaon,Dist.Ahmadnagar, Maharashtra
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
8550991815 |
| Fax |
|
| Email |
maheshdolas23@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO.102 SHALAKYA TANTRA DEPARTMENT, SHRI EKNATH AYURVED RUGNALAYA, PMTs Ayurveda College, Shevgaon Akhegaon road,Tal.Shevgaon , Dist.Ahmadnagar, Maharashtra -414502, India |
|
|
Primary Sponsor
|
| Name |
PMTs Ayurveda College , Shevgaon |
| Address |
Shevgaon,Tal.Shevgaon,Dist.Ahmadnagar, Maharashtra 414502 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrRajani Suresh Navale |
PMTs Ayurveda College , Shevgaon |
SHALAKYA TANTRA DEPARTMENT,OPD NO 102,SHRI EKNATH AYURVED RUGNALAYA, PMTs Ayurveda College, Shevgaon Akhegaon road,Tal.Shevgaon,Dist.Ahmadnagar, Maharashtra
Ahmadnagar
MAHARASHTRA |
7798490388
rajaninavale92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H101||Acute atopic conjunctivitis. Ayurveda Condition: VATABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | biDAlaka:, बिडालक: | (Procedure Reference: , Procedure details: Procedure reference: Charak Samhita Chikitsa Sthan 26, Procedure details Bidalak is performed with the patient laying in a supine position.
Purvakarma :
Whole body shodhan.Paste should be semisolid , mrudu snehan,swedan on face & lids to relax the patient & increase local validation for better absorption.
Pradhankarma:
Lukewarm paste Bidalak patient ask to close eyes & paste apply closed eyes in circle except lid margin & eye lashes.
Keep eye closed.
Thickness of lepa is according to severity of diseases & aggravation of doshas.
Pachatkarma :
Skin wiped with cotton swab & lukewarm water.
Wiping should be done before lepa get dried.
This procedure is done on 40 patients who are included Group A for intervention for 3 days & then paitents symptoms are observed on 0, 3, 6, 9, 12, 15th day )
| | 2 | Comparator Arm | Procedure | - | biDAlaka:, बिडालक: | (Procedure Reference: , Procedure details: Procedure reference: Charak Samhita Chikitsa Sthan 26, Procedure details Bidalak is performed with the patient laying supine position
Purvakarma:
Whole body shodhan.
Paste should be neither thick nor thin it is semisolid.
Mrudu snehan, swedan on face & lids to relax the patient & increase local validation for better absorption
Pradhankarma :
Lukewarm paste GHRUTA Brustha Haritaki Bidalak paitent ask to close eyes & paste apply closed eyes in circle except lid margin & eye lashes.
Keep eye closed.
Thickness of lepa is according to severity of diseases & aggravation of doshas.
Pachatkarma :
Skin wiped with cotton swab & lukewarm water.
Wiping should be done before lepa get dried.
This procedure is done on 40 patients which are included in Group B for every 3 days follow up & then paitents symptoms are observed on 0, 3, 6, 9, 12, 15th day.)
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|
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Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Paitents with signs and symptoms of Vataj Abhishyand like Toda, Sangharsh, Shishirashruta, Alpashopha, Shirobhitapa.
Irrespective of their sex,race religion and economic status barrier. |
|
| ExclusionCriteria |
| Details |
Abhishyanda associated with other occular and systemic diseases.
Patient having known case of HbsAg and HIV.
Paitent having any corneal involvement like corneal opacity, corneal ulcer.
One Eyed patient and patient recently operated for eye disease.
Paitent having any adverse drug reaction.
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Ghruta Bhrusta Shabarak Lodhra Bidalak in Vataj Abhishyand
Is there any reduction in symptoms or frequency of symptoms of Vataj Abhishyand ( Acute allergic conjunctivitis) that will be assessed after 15 days |
15 days treatment with 6 follow up 0, 3, 6, 9, 12, 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To review the ayurvedic literature regarding Vataj Abhishyand.
To review information about Bidalak kalpana in details.
To review the modern literature regarding simple allergic conjunctivitis.
To evaluate effect of Gruta Bhrusta Haritaki Bidalak.
To evaluate effect of Gruta Bhrusta Shabarak Lodhra Bidalak with Ghruta Bhrusta Haritaki Bidalak in Vataj Abhishyand.
To observe any adverse drug reaction |
15 days treatment with 6 follow up 0, 3, 6, 9, 12, 15th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
18/08/2025 |
| 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="0"
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
|
The prevalence of ocular allergy ranged from 5.22% with geographical veriation depending on the age distribution of the population and the subtype of occular allergy. Drugs in modern pharmacology have multiple pharmacological mechanism of actions such as histamine H1 receptor, antagonists, mast cell stabilizers, etc. which are useful in treatment of allergic conjunctivitis but they may settle in developing Acute Respiratory distress syndrome & possibilities of relapses are also present . 1. Vataj Abhishyanda successful treatment cures many disease in their primary stage only. 2 .The drug taken for the study in very cost effective , all needy patients can also afford it . 3.The most primary disease but much neglected by society, so this research work will be very helpful regarding to this disease. Hence , there is a scope to search for a better remedy from the rich heritage of ophthalmic preparations available in Ayurveda. A study of ’ Ghrita Bhrusta Shabarak Lodhra Bidalak ’ has not been taken before. It contains Chakshusha dravyas, having Vatagna properties & also the dravyas in ’ Ghrita Bhrusta Shabarak Lodhra Bidalak ’ are easily available. Hence, study will be done to overcome all the above problems. Thus the need of study is to access a more effective treatment with herbal formulation for Vataj Abhishyanda |