| CTRI Number |
CTRI/2026/02/103426 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Feasibility study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Preperatio of Standard Operative Procedure for Seka and Aschyotana of Netra Kriyakalpa
Local procedure for eye diseases) and their Feasibility in redness of eyes |
|
Scientific Title of Study
|
A Clinical Consensus study for developing Standard Operative Procedure and Practice Guidelines of Seka and Aschyotana of Netra Kriyakalpa with a Feasibility study in 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 Kamble Pallavi Namdev |
| Designation |
Research Officer (Ay.) |
| Affiliation |
Regional Ayurveda Research Institute Lucknow |
| Address |
21/1119, Indiranagar, Lucknow
Uttar Pradesh- 226016
INS-106, Sector 25, Indira Nagar, Lucknow
Uttar Pradesh- 226016
Lucknow
UTTAR PRADESH
226016
India |
| Phone |
8955325835 |
| Fax |
|
| Email |
drpallavikamble24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamble Pallavi Namdev |
| Designation |
Research Officer (Ay.) |
| Affiliation |
Regional Ayurveda Research Institute Lucknow |
| Address |
21/1119 Indira Nagar, Lucknow
Uttar Pradesh- 226016
INS-106, Sector 25, Indira Nagar, Lucknow
Uttar Pradesh- 226016
Lucknow
UTTAR PRADESH
226016
India |
| Phone |
8955325835 |
| Fax |
|
| Email |
drpallavikamble24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamble Pallavi Namdev |
| Designation |
Research Officer (Ay.) |
| Affiliation |
Regional Ayurveda Research Institute Lucknow |
| Address |
21/1119, Indira Nagar, Lucknow
Uttar Pradesh- 226016
INS-106, Sector 25, Indira Nagar, Lucknow
Uttar Pradesh- 226016
Lucknow
UTTAR PRADESH
226016
India |
| Phone |
8955325835 |
| Fax |
|
| Email |
drpallavikamble24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences (C.C.R.A.S),D block,janakpuri New delhi India- 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences (C.C.R.A.S) |
| Address |
Jawaharlal Nehru Bhartiya Chikisa Evam Homeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D-Block
Janakpuri, New Delhi –110058.
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kamble Pallavi Namdev |
Regional Ayurveda Research Institute Lucknow |
INS-106, Sector 25, Indira Nagar, Lucknow
Uttar Pradesh- 226016
INS-106, Sector 25, Indira Nagar, Lucknow
Uttar Pradesh- 226016
Lucknow
UTTAR PRADESH |
08955325835
drpallavikamble24@gmail.com |
| Dr Kumari Archana |
Regional Ayurveda Research Institute Patna |
“D" Block, RMRIMS Building, AgamKuan, Patna-800007 (Bihar)
Patna
BIHAR |
7046074206
archana06bly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| RARI LUCKNOW |
Approved |
| RARI Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H10||Conjunctivitis. Ayurveda Condition: ABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | AScyotanam, आश्च्योतनम् | (Procedure Reference: Sushrut Samhita,Ashtang Hriday, Procedure details: Kwatha preparation mentioned as per the ayurvedic classic)
(1) Medicine Name: Tri[hala Churna, Reference: AFI, Part I,Pg.No. 323, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: od, Duration: 5 Days(2) Medicine Name: Triphala Churna, Reference: AFI, Part I,Pg.No. 323, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 5(ml), Frequency: od, Duration: 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of age 18-40 years
2.Subjects presenting with signs and symptoms of chronic allergic conjunctivitis
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.Participants having any complications with corneal involvement, conjunctivitis other than allergic, positive for conjunctival smear and culture,
2.disease of lachrymal system,genetic predisposition to allergy,concurrent co-morbid serious hepatic disorder, renal disorders, severe pulmonary dysfunction,
3.uncontrolled diabetes mellitus or poorly controlled hypertension
4.Uncontrolled diabetes mellitus and Uncontrolled hypertension
5.Subjects with concurrent Hepatic Dysfunction or Renal Dysfunction,uncontrolled Pulmonary Dysfunction.
6.pregnant or lactating females
7.patients on steroids, oral contraceptive pills, estrogen replacement therapy
8.smokers,alcoholics,drug abusers
9.patients on long-term drug treatment as in rheumatoid arthritis, psycho-neuro-endocrinal disorders
10.hypersensitivity to any of the ingredients of the trial drug
11.patients who have undergone any clinical trial during past 6 months were excluded from the study.
12.Any other condition which the Investigator thinks may jeopardize the study.
13.Subjects who refuse to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The feasibility and acceptability of the standardized procedures of Seka and Aschyotana will be assessed by the procedure completion rate (proportion of participants who successfully complete the procedures as per protocol), protocol adherence rate (compliance with procedural steps and post-procedure care), and tolerability of the procedures, evaluated in terms of participant comfort, occurrence of adverse events, and overall acceptance from baseline to the end of the intervention period. |
Baseline and at the end of the study 6th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. The symptomatic improvement in Itching, lacrimation, photophobia, foreign body sensation, burning sensation, lid swelling assessed by VAS (0–100 scale) and redness assessed by grading of scores at every visit . |
Baseline and at the end of the study 6th 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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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="5"
Days="0" |
|
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
|
kriyaklpas are the specilized local
therapeutic (sthaniya chikitsa) procedures indicated for netraroga in various
ocular conditions. As panchakarma therapy is important for kaychikitsa same as
kriyakalpa therapy plays important role in treating various netraroga in
shalakya . It includes Tarpana, Putapaka, Seka, Aschyotana, Anjana, Bidalaka
and Pindi.Seka and Aschyotana, one of
the frequent used kriyakalp therapy to cure netrarogas .Aschyotana
is first line of treatment in eye diseases. Seka and Aschyotana both therapies are indicated
in acute phase or aamavastha in eye diseases. The practice of seka and aschyotana varies across different
parts of the country and among the practicing physicians. There lies the
relevance of standardization of different aspects of seka and aschyotana
procedure.
The purpose of the current study is to
scientifically standardize the seka and aschyotana procedure in terms of purva ,pradhan and paschyat karma includes
prepeartion of kwathdrvya with aseptic precaution, maintain temperature of
prepared medicine, storage, time and
dose in order to ensure safety and significantly increase procedural efficacy.
Stage1: Clinical Consensus Study -The RAND/UCLA Appropriateness Method (RAM) is indeed a widely
recognized technique used to assess the appropriateness of medical and surgical
interventions. It involves gathering expert opinions through a structured
process to evaluate the appropriateness of specific healthcare procedures or
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 analyzed to provide insights into the appropriateness of
those interventions. This information can be used to develop standardized
practice guidelines, improve healthcare quality, and inform decision-making in
clinical settings. Two-Round Rating Process:
In the first round, panellists individually rate the
appropriateness of medical procedures. There is no interaction among panellists
during this phase.
In the second round, panel members come together
for 1-2 days under the guidance of a moderator experienced in using the method.
This face-to-face interaction allows for discussions and further clarification. Stage 2: Feasibiltity Study-The feasibility and acceptability of the standardized
procedures of Seka and Aschyotana will be assessed by the
procedure completion rate (proportion of participants who successfully complete
the procedures as per protocol), protocol adherence rate (compliance with
procedural steps and post-procedure care), and tolerability of the procedures,
evaluated in terms of participant comfort, occurrence of adverse events, and
overall acceptance from baseline to the end of the intervention period |