| CTRI Number |
CTRI/2025/03/083322 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of darvyadi eye drops in Kaphaja Abhishyanda (acute mucopurulent conjunctivitis) |
|
Scientific Title of Study
|
An open labelled randomized controlled clinical study to evaluate the efficacy of darvyadi eye drops in the management of kaphaja abhishyanda with special reference to acute mucopurulent 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 Ravi Shanker Pareek |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room no 406 Department of Shalakya Tantra Parul Institute of Ayurved Parul
University limda Tal Waghodia
Room no 406 Department of Shalakya Tantra Parul Institute of Ayurved Parul
University limda Tal Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
09636904383 |
| Fax |
|
| Email |
ravipareek132@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalaka More |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room no 406 Department of Shalakya Tantra Parul Institute of Ayurved Parul
University limda Tal Waghodia
Room no 406 Department of Shalakya Tantra Parul Institute of Ayurved Parul
University limda Tal Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
7057894025 |
| Fax |
|
| Email |
vdshalakapawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Shanker Pareek |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room no 406 Department of Shalakya Tantra Parul Institute of Ayurved Parul
University limda Tal Waghodia
Room no 406 Department of Shalakya Tantra Parul Institute of Ayurved Parul
University limda Tal Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
09636904383 |
| Fax |
|
| Email |
ravipareek132@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved Parul University limda Vadodara Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul University Vadodara Gujarat 391760 |
| 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 |
| Dr Ravi Shanker Pareek |
Parul Ayurved Hospital |
Department of Shalakya Tantra EYE
OPD No 108 Parul Ayurved Hospital
Parul University Limda Waghodia
Vadodara
GUJARAT
9636904383
Vadodara
GUJARAT |
09636904383
ravipareek132@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics CommitteeParul Institute of Ayurved Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H100||Mucopurulent conjunctivitis. Ayurveda Condition: KAPABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | ciprofloxacin eye drops | Ciprofloxacin Hydrochloride 0.3%
Benzalkonium Chloride 0.01% | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darvyadi Eye Drops, Reference: Sushruta Samhita Uttartantra Adhyaya 11 Shloka 6, Route: Topical, Dosage Form: Arka, Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients presenting with the signs and symptoms of Kaphaja Abhishyanda will be selected
2 Patients irrespective of Gender religion and socio-economic status will be included in study |
|
| ExclusionCriteria |
| Details |
1 Patients not willing to participate in the study
2 Severe cases of conjunctivitis with complications like corneal ulcers trachoma dacryocystitis etc
3 Eye associated with any other inflammatory and infective ocular conditions
4 Patients with known case of Hypertension Diabetes mellitus and any major systemic illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of efficacy of darvyadi eye drops and Ciprofloxacin eye drops
2.Comparison of efficacy of darvyadi eye drops and ciporifloxacin eyedrops in the management ofkaphaj abhiushyanda with special reference to acute mucopurulent conjunctivitis
3.Reduction in redness and discharge
4.Relief from discomfort and itching sensation
5.Vision restoration |
Baseline DAY 1
DAY 8
DAY 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms of acute mucopurulent conjunctivitis |
15 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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 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
|
1.Acute mucopurulent conjunctivitis is often under diagnosed and consequently under treated. 2. Acute mucopurulent conjunctivitis is the most common prevalence is India rate 17.23–22.52 %. 3. Cases of Kaphaja Abhishyanda (Acute mucopurulent Conjunctivitis) is frequently seen in OPD of Shalakya tantra on a routine basis. 4. There is a need to develop a therapy that is without side effect and less expensive. 5. We have tried to prepare Darvyadi eye Drops in order to get over these challenges and make ayurvedic procedures more patients friendly. 6.Many patients are unable to visit the hospital for a fairly straightforward procedure due to a fast- paced lifestyle, hectic working hours, as well as other unavoidable factors. 7.The purpose of the study is to compare the Darvyadi eye Drops with ciprofloxacin eye Drops (0.3%), in Kaphaja Abhishyanda under the identical circumstances |