| CTRI Number |
CTRI/2023/02/049823 [Registered on: 17/02/2023] Trial Registered Prospectively |
| Last Modified On: |
16/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial of local installation of herbal eye drops in eyes for conjunctivitis |
|
Scientific Title of Study
|
"Randomised Open Comparative Clinical Study Of Bilavadi Yoga Aschyotana And Triphala
Kwatha Aschyotana In Vataj Abhishyanda W.S.R To Allergic Conjunctivitis" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sayali Sahebrao Rathod |
| Designation |
PG scholar |
| Affiliation |
Maharashtra University of health sciences nashik |
| Address |
Yashwant ayurvedic medical College PGT and RC and hospital Kodoli dist Kolhapur
Shalakyatantra department
OPD no - 16 Ground floor
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
09763734704 |
| Fax |
|
| Email |
sayalirathod89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr chandrashekhar mule |
| Designation |
HOD and PG Guide professor of Shalakyatantra department |
| Affiliation |
Maharashtra University of health sciences nashik |
| Address |
Yashwant ayurvedic medical College PGT and RC Kodoli dist Kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9175800710 |
| Fax |
|
| Email |
drcnm05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr chandrashekhar mule |
| Designation |
HOD and PG Guide professor of Shalakyatantra department |
| Affiliation |
Maharashtra University of health sciences nashik |
| Address |
Yashwant ayurvedic medical College PGT and RC Kodoli dist Kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9175800710 |
| Fax |
|
| Email |
drcnm05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic medical College PGT and RC Kodoli dist Kolhapur Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Sayali Sahebrao Rathod |
| Address |
Yashwant ayurvedic hospital Kodoli kolhapur |
| 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 Sayali Sahebrao Rathod |
Yashwant ayurvedic College and hospital Kodoli kolhapur |
Shalakyatantra department
OPD no - 16 Ground floor
Kolhapur
MAHARASHTRA |
9763734704
sayalirathod89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H108||Other conjunctivitis. Ayurveda Condition: Ayurveda , (2) ICD-10 Condition:H108||Other conjunctivitis. Ayurveda Condition: VATAJA-NETRAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | AScyotanam, आशà¥à¤šà¥à¤¯à¥‹à¤¤à¤¨à¤®à¥ | (Procedure Reference: Shushrut samhita , Procedure details: Bilvadi yoga aschyotana and Triphala kwatha aschyotana 10-12bindu in each eye for 15days dharan kal 100matra)
(1) Medicine Name: Bilvadi yoga , Reference: Triphala kwatha , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 10(drops), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of age group 16to 60years.Irresprctive of gender, religion,marital status.Unilateral and Bilateral vataj Abhishyanda |
|
| ExclusionCriteria |
| Details |
Patients having corneal involmemt .patient having complicated systemic diseases like RA SLE |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the decrease in symptoms of Vataj Abhishyanda in terms of subjective criteria like nistodana , sangharsh and netrastrava and in terms of objective criteria like raga,vartmashotha and shishirshruta |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To review the literature about Aschyotana
2 To review the literature about Vataj Abhishyanda
3 To review the literature about Allergic Conjunctivitis
4 To evaluate effect of Bilvadi yoga Aschyotana and Triphala kwatha Aschyotana In signs and symptoms of Vataj Abhishyanda
5 To evaluate the effect of Bilvadi yoga Aschyotana and Triphala kwatha Aschyotana In signs and symptoms of Allergic Conjunctivitis |
18month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/02/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is Randomised open comparative clinical study of Bilavadi yoga aschyotana and Triphala kwatha aschyotana in vataj abhishyanda w.s.r to Allergic conjunctivitis.study will be carried in od of Shalakyatantra department of Yashwant ayurvedic College and hospital Kodoli kolhapur.The observation would be drawn on the basis of symptoms after treatment given |