| CTRI Number |
CTRI/2024/02/062841 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Nimba patra pindi and shigru patra pindi in the management of kaphaj abhishyanda w.s.r. to acute mucopurrulent conjunctivitis |
|
Scientific Title of Study
|
A comparative clinical study on effect of nimba patra pindi and shigru patra pindi in the management of kaphaj abhishyanda w.s.r. to acute mucopurrulent conjunctivitis |
| Trial Acronym |
N/A |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GAURAV PANYA |
| Designation |
P.G. Scholar |
| Affiliation |
Mansarover Ayurvedic Medical college Hospital and Research center |
| Address |
Department of Shalakya Tantra first floor room number 1, Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam, Kolar road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
8989900121 |
| Fax |
|
| Email |
gauravujjain99934@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. Arunima Namdeo |
| Designation |
Professor and Head of Department |
| Affiliation |
Mansarover Ayurvedic Medical College Hospital And Research Center |
| Address |
Department of Shalakya Tantra first floor room number 1, Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam, Kolar Road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9179832716 |
| Fax |
|
| Email |
arunimasyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GAURAV PANYA |
| Designation |
P.G. Scholar |
| Affiliation |
Mansarover Ayurvedic Medical college Hospital and Research center |
| Address |
Department of Shalakya Tantra first floor room number 1, Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam, Kolar road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
8989900121 |
| Fax |
|
| Email |
gauravujjain99934@gmail.com |
|
|
Source of Monetary or Material Support
|
| MANSAROVER AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESERCH CENTER, Bhopal |
|
|
Primary Sponsor
|
| Name |
DR GAURAV PANYA |
| Address |
Department of Shalaka Tantra first floor room number 1, Mansarovar Ayurvedic Medical college Hospital and Research center Hinotiya Alam, Kolar road, Bhopal |
| Type of Sponsor |
Other [Self ] |
|
|
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 GAURAV PANYA |
Mansarovar Ayurvedic Medical college Hospital and Research center |
Department of Shalakya Tantra first floor room number 1, Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam, Kolar road, Bhopal
Bhopal
MADHYA PRADESH |
8989900121
gauravujjain99934@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mansarovar Ayurvedic Medical college Hospital and Research center Bhopal |
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 | Intervention Arm | Procedure | - | piNDI, पिणà¥à¤¡à¥€ | (Procedure Reference: Sarangdhar samhita , Procedure details: Once a day in the morning )
(1) Medicine Name: Nimba patra Pindi , Reference: Sarangdhar samhita , Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | piNDI, पिणà¥à¤¡à¥€ | (Procedure Reference: Sarangdhar samhita , Procedure details: Once in a day at morning )
(1) Medicine Name: Shigru Patra Pindi , Reference: Sarangdhar samhita , Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptoms of kaphaj Abhishyanda w.s.r. to (Acute Mucopurulent Conjunctivitis) |
|
| ExclusionCriteria |
| Details |
1. Patients having major eye problems like corneal ulcer, Severe eye injuries etc.
2. Patients having major systemic disease like tuberculosis etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of Nimba patra Pindi and Shigru Patra Pindi in the management of kaphaj Abhishyanda |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study Kaphaj Abhishyanda & Acute Mucopurulent Conjunctivitis & to study mode of action of Nimba patra Pindi & Shigru Patra Pindi. |
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)
|
28/02/2024 |
| 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
|
Total 60 patients will be randomly selected and divided into 2 groups one group will be treated with Nimba Patra Pindi, second group will be treated with Shigru Patra Pindi and to evaluate and compare the effect on kaphaj abhishyanda w.s.r. to acute mucopurrulent conjunctivitis |