| CTRI Number |
CTRI/2023/07/055245 [Registered on: 14/07/2023] Trial Registered Prospectively |
| Last Modified On: |
08/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To evaluate the efficacy of Tilvakadi paste application and tilvakadi eyedrop instillation in the management of burning sensation in eyes |
|
Scientific Title of Study
|
AN OPEN LABELLED RANDOMISED CONTROLLED CLINICAL TRIAL OF TILVAKADI PINDI AND TILVAKADI EYE DROP IN PITTAJ ABHISHYANDA |
| Trial Acronym |
An open labelled randomised controlled clinical trial of Tilvakadi Pindi AND Tilvakadi Eyedrop in Pittaj Abhishyanda |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivkant Sharma |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD-108, Parul Ayurveda Hospital, Shalakya tantra department, Parul
institute of Ayurveda, Parul University, At Post-Limda, Tal- Waghodia,
VADODARA, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8847864068 |
| Fax |
|
| Email |
shivkants@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surabhi Khare |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD-108,Parul Ayurveda Hospital, Shalakya tantra department, Parul
institute of Ayurved, Parul University, At Post-Limda, Tal- Waghodia,
VADODARA, Gujarat
391760
Vadodara
GUJARAT
391760
India |
| Phone |
7880112800 |
| Fax |
|
| Email |
kharesurbhi11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surabhi Khare |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD-108,Parul Ayurveda Hospital, Shalakya tantra department, Parul
institute of Ayurved, Parul University, At Post-Limda, Tal- Waghodia,
VADODARA, Gujarat
391760
Vadodara
GUJARAT
391760
India |
| Phone |
7880112800 |
| Fax |
|
| Email |
kharesurbhi11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurved Hospital, Parul Institute of Ayurved, Parul university, Vadodara Gujarat |
|
|
Primary Sponsor
|
| Name |
Dean Parul Institute of Ayurved |
| Address |
Parul Ayurved hospital, Parul
institute of Ayurveda, Parul University, At Post-Limda, Tal- Waghodia,
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 Surabhi Khare |
Parul Institute of Ayurved |
OPD-108,Parul Ayurveda hospital, Shalakya tantra department, Parul
institute of Ayurveda, Parul University, At Post-Limda, Tal- Waghodia,
VADODARA, Gujarat. 391760
Vadodara
GUJARAT |
7880112800
kharesurbhi11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H103||Unspecified acute conjunctivitis. Ayurveda Condition: PITTABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tilvakadi Eyedrops , Reference: Yogaratnakara Samhita, Netraroga Chikitsa, Shloka number 370, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Procedure | - | piNDI, पिणà¥à¤¡à¥€ | (Procedure Reference: Sarangadhara samhita, Uttara khanda, Chapter 13, Shloka number 21, Procedure details: Take powder of Raktachandana, Madhuka, Lodhra, Jatipushpa and Gairika in equal proportion and mixed with water to form a paste and kept in a thin cotton cloth used as a Pindi for local application.)
(1) Medicine Name: Tilvakadi Pindi, Reference: Yogaratnakara Samhita, Netraroga Chikitsa, Shloka number 370, Route: Ocular, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Duration: 7 Days | | 3 | Comparator Arm | Procedure | - | piNDI, पिणà¥à¤¡à¥€ | (Procedure Reference: Sarangadhara samhita, Uttara khanda, Chapter 13, Procedure details: Take the powder of Amalaki fruit (Emblica officinalis) mixed with water to form a paste and kept in a thin cotton cloth used as a Pindi for local application. )
(1) Medicine Name: Amalaki Pindi, Reference: Sarangadhara samhita, Uttara khanda, Chapter 13, Shloka number 26, Route: Ocular, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group between 18 to 50 years of age.
Patients presenting with signs and symptoms of Pittaj Abhishyanda.
Patient’s irrespective of gender, caste, socioeconomic status etc.
|
|
| ExclusionCriteria |
| Details |
Patients having complication like marginal corneal ulcer, trachoma, dacryocystitis, infective conjunctivitis etc.
Patient with concurrent serious systemic illness like diabetes mellitus, hypertension, hepatitis etc.
Patient who are not willing for trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient will get relief from symptoms like burning sensation and watering from eyes |
0th day, 8th day, 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient will get relief from symptoms like foreign body sensation, photophobia and redness in eyes |
0th day, 8th day, 15th day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3 |
|
Date of First Enrollment (India)
|
16/08/2023 |
| 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="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
|
These days, eye problems are most frequently seen due to a variety of etiological factors. The protection of the eye is given significant priority in all areas of research because it is one of the primary sense organs. Pittaj Abhishyanda is frequently seen in our OPD on a routine basis. Because of direct exposure to heat, cold, sunlight, dust particle and etc. It happens rather often. In view of the magnitude of the disease the discomfort it causes to the patients and cost of the treatment, there is need to develop a therapy which is free from side effect, cheaper and has a significant effect in reduce the symptoms of the patient. 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. We have tried to transform the Pindi Kriyakalpa into an eyedrops in order to get over these challenges and make ayurvedic procedures more patient-friendly. So instead of changing the drug, we alter the form of medicine. When compared to Pindi, using eyedrops saves time. |