| CTRI Number |
CTRI/2026/01/102054 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study for the development of guidelines and for standardization of bidalaka ayurvedic eye procedure and to evaluate the feasibility study in Abhisyanda |
|
Scientific Title of Study
|
A Clinical Consensus study for developing the practice guidelines and Standardization of Bidalaka with a Feasibility study in Abhisyanda |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandini Murli Jadhav |
| Designation |
Research officer (Ay.) |
| Affiliation |
Regional Ayurveda Research Institute for Mineral and Marine Medicinal Resources Goa (RARIM&MMR) |
| Address |
OPD BLOCK,Ground floor, ROOM NO 2,EYE OPD Department of Shalakya Tantra Rarim&MMR Old G.M.C Building Ribandar Panaji Goa
403006
India
North Goa
GOA
403006
India |
| Phone |
8446318914 |
| Fax |
|
| Email |
nandina.punarvasu84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandini Murli Jadhav |
| Designation |
Research officer (Ay.) |
| Affiliation |
Regional Ayurveda Research Institute for Mineral and Marine Medicinal Resources Goa (RARIM&MMR) |
| Address |
OPD BLOCK,Ground floor, ROOM NO 2,EYE OPD Department of Shalakya Tantra Rarim&MMR Old G.M.C Building Ribandar Panaji Goa
403006
India
North Goa
GOA
403006
India |
| Phone |
8446318914 |
| Fax |
|
| Email |
nandina.punarvasu84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandini Murli Jadhav |
| Designation |
Research officer (Ay.) |
| Affiliation |
Regional Ayurveda Research Institute for Mineral and Marine Medicinal Resources Goa (RARIM&MMR) |
| Address |
OPD BLOCK,Ground floor, ROOM NO 2,EYE OPD Department of Shalakya Tantra Rarim&MMR Old G.M.C Building Ribandar Panaji Goa
403006
India
North Goa
GOA
403006
India |
| Phone |
8446318914 |
| Fax |
|
| Email |
nandina.punarvasu84@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi , Ministry of Ayush, Govt of India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences CCRAS |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homeopathy Anusandhan Bhawan 61-65 ,Institutional Area ,Opposite D-Block ,Janakpuri ,New Delhi 110058,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 Nandini Murli Jadhav |
Regional Ayurveda Research Institute for Mineral and Marine Medicinal Resources Goa (RARIM&MMR) |
Old G.M.C Building Ribandar Panaji Goa
North Goa
GOA |
08446318914
nandina.punarvasu84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Ayurveda Research Institute for Mineral and Marine Medicinal Resources Goa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H104||Chronic conjunctivitis. Ayurveda Condition: ABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | biDAlaka:, बिडालक: | (Procedure Reference: SHARANGDHAR SAMHITA , Procedure details: Form:kalka/paste ,Frequency-OD ,Duration: 7days )
(1) Medicine Name: Triphala churna , Reference: sharangdhar samhita , Route: Ocular, Dosage Form: Kalka/ Paste, Dose: 10(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of age 10-60 years
2.Subjects presenting with swelling of eyelids due to inflammation.
3.Subjects who agree to participate in the study and submit a written informed consent form
4.Willing and able to participate for 1 week
|
|
| ExclusionCriteria |
| Details |
1.Subjects who have active corneal ulceration, corneal opacity, keratitis,trauma etc
2.Pregnant/ Lactating females
3.Alcoholics and/or drug abusers
4.Patients with evidence of malignancy
5.H/O Hypersensitivity to the trial drug or any of its ingredients
6.Subjects who have completed participation in any other clinical trial during the past six months.
7.Any other condition which the Investigator thinks may jeopardize the study.
8.Subjects who refuse to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The feasibility and acceptability of the standardized procedure of bidalaka assessed in terms of procedure completion rate
Protocol adherence rate after care and tolerability of procedure |
Base line treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any SAE/ADR |
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2026 |
| 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="0"
Months="0"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Netra Kriyakalpa is a topical therapeutics performed in Ayurvedic ophthalmology. It involves a specific procedure using a prescribed formulation for proper application to the (retention of medicated ghee), Putapaka (retention of extracts of medicinal plants), Seka (medicated solution poured as stream), Aschyotana (eye drops), Anjana (ointments), Pi and adnexa). Ayurveda certainly recommends a number of methodological guidelines that are specifically designed in accordance with the stage, site and severity of the disease in optimum outcome. The Ocular therapeutics such as bidalaka mentioned in Ayurveda Samhita’s differs in factors such as dosage form, consistency of medicine the administration, safety instructions, quality indicators, and therapeutic benefit evaluation. Standardization is required to ensure uniformity in the quality and integrity of the proceed critical guidelines for kriyakalpa procedures like bidalaka in terms of dosage form, temperature, time, height, quality, and feasibility in order to promote consistent. This study is done in 2 stages, Stage 1 is Clinical consensus study to to develop standard operative procedure and practice guidelines for Bidalaka kriyakalpa procedure using the RAND/UCLA Appr recognized technique used to assess the appropriateness of medical and surgical interventions. It involves gathering expert opinions through a structured process to evaluate the treatments. The method involves a panel of experts who independently review and rate the appropriateness of specific medical procedures. Their opinions are then aggregated and of those interventions. This information can be used to develop standardized practice guidelines, improve healthcare quality, and inform decision-making in clinical settings. I “Modified Delphi” process. This method is a structured communication technique that involves a group of experts providing feedback in a series of rounds, with the goal of re usually involves iterative rounds of feedback and may include face-to-face interactions. The two-Round Rating Process includes, in the first round, panellists individually rate the interaction among panellists during this phase. and in the second round, panel members come together for 1-2 days under the guidance of a moderator experienced in using discussions and further clarification.
Stage 2 is the Feasibility study where Feasibility of Bidalaka procedure with standardized dose, duration and procedure at OPD level, RARIM & MMR is done with the objective to assess the feasibility and acceptability of the standardized procedure of Bidalaka in Abhisyanda |