| CTRI Number |
CTRI/2025/09/094582 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homeopathic For Red Eye in 5 to 25 yrs by Totality of Symptoms |
|
Scientific Title of Study
|
Homeopathic Management Of Acute Conjunctivitis In The Age Group Of 5 To 25 Years Based On Totality Of Symptoms |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajubhai Raymalbhai Sarla |
| Designation |
MD Scholar |
| Affiliation |
Rajkot Homeopathic Medical College ,Parul University |
| Address |
batiya fali, Palasha
, Muli
, Surendranagar
Rajkot Homeopathic Medical College,Parul University
Behind Jainath Complex,Makkam Chowk,Gondal Road,Rajkot,Gujrat 360002
Rajkot
GUJARAT
363510
India |
| Phone |
9429646443 |
| Fax |
|
| Email |
rajusarla914@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mital Kacha |
| Designation |
Assistant Professor |
| Affiliation |
Rajkot Homeopathic Medical College,Parul University |
| Address |
Narayan Nivas
3 Girnar Society,opposite Ankur Vidhiyalaya,b/h Guruprasad Chowk,Near Hj Doshi Hospital
Behind Jainath Complex,Makkam Chowk,GondalRoad,Rajkot,Gujrat360002
Rajkot
GUJARAT
360004
India |
| Phone |
9099144019 |
| Fax |
|
| Email |
dr.mitalkacha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajubhai Raymalbhai Sarla |
| Designation |
MD Scholar |
| Affiliation |
Rajkot Homeopathic Medical College,Parul University |
| Address |
Batiya fali,Palasha
,Muli, Surendranagar
Behind Jainath Complex,Makkam Chowk,Gondal Road,Rajkot ,Gujrat 360002
Rajkot
GUJARAT
363510
India |
| Phone |
9429646443 |
| Fax |
|
| Email |
rajusarla914@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homeopathic Medical College,Behind Jainath Complex,Makkam Chowk,Gondal Road,Rajkot,360002,Gujrat,India |
|
|
Primary Sponsor
|
| Name |
Sainath Hospital |
| Address |
Rajkot Homeopathic Medical College,Behind Jainath Complex,Makkam Chowk,Gondal Road ,Rajkot,36002,Gujrat,India |
| 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 |
| Rajubhai Raymalbhai Sarla |
Sainath Homeopathic Hospital |
101 Medicine,Organon Of Medicine And Homeopathic Philosophy,Rajkot Homeopathic Medical College,Behind Jainath Complex,Makkam Chowk,Gondal Road,Rajkot,Gujrat
Rajkot
GUJARAT |
9429646443
rajusarla914@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe For Human Research Rajkot Homeopathic Medical College[RHMC],Parul University,Gujrat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H102||Other acute conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
"Homeopathic Management Of Acute Conjunctivitis In The Age Group Of 5 To 25 Years Based On Totality Of Symptoms" |
Type of Trial: Interventional Single Arm Open Label Prospective Clinical Study
Intervention: Individualized
homeopathic medicines prescribed based on the totality of symptoms according to Organon of Medicine aphorisms 83 to 104
Population: 40 patients in the age group 5 to 25 years diagnosed with acute conjunctivitis
Study Site: OPD of Sainath Homeopathic Hospital Rajkot Homeopathic Medical College and Hospital Parul University
Duration: 12 months
Design: Patients will receive individualized remedies Outcomes will be assessed before and after treatment using the Ocular Assessment Scale OAS
Primary Objective: To evaluate the effectiveness of individualized homeopathic management in reducing symptoms of acute conjunctivitis
Outcome Measures: Reduction in OAS score and clinical improvement classified as marked moderate mild or no improvement
Comparator agent :Nil(single arm study)
Intervention time is 1 to 2 weeks |
| Comparator Agent |
Nil |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of all genders aged 5–25 years diagnosed with acute conjunctivitis.
2. Cases with classical symptoms such as redness, watery discharge, burning sensation, photophobia, and itching.
3. Patients who provide informed consent and agree to follow-up visits. |
|
| ExclusionCriteria |
| Details |
1. Patients with chronic or recurrent conjunctivitis.
2. Patients with associated systemic conditions that may influence symptom progression.
3. Pregnant and lactating women.
4. Patients unable to comply with the study protocol and follow-up schedule. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Ocular Assessment Scale (OAS) score before and after individualized homeopathic treatment in patients of acute conjunctivitis, measured over the study duration of 12 months.
This captures:
The outcome measure = OAS score
The comparison = pre- and post-treatment
The timeframe = study duration |
Baseline (pre-treatment), at 3 to 5 days follow-up, and subsequently until resolution of symptoms within the 12-month study duration.
it out come in time is 1 to 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of symptom resolution & improvement in individual symptoms (redness, discharge, photophobia, itching). |
Baseline & follow-up at 3–5 days, continued until symptom resolution within 12 months.
its out come show assessment at 1 to 2 weeks. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/09/2025 |
| 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
|
This study will evaluate the effectiveness of homeopathic medicine in managing acute conjunctivitis in patients aged 5 to 25 yrs.Patients will be given individualised remedies based on their totality of symptoms.Improvement will be assessed using clinical observation and the ocular assessment scale before and after treatment.The aim is to provide a safe and holistic approach to reduce redness,discharge, and discomfort in acute conjunctivitis. |