| CTRI Number |
CTRI/2023/08/056223 [Registered on: 07/08/2023] Trial Registered Prospectively |
| Last Modified On: |
11/07/2023 |
| 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
|
A clinical trial to study the comparative effectiveness of Haritaki as a single drug & Haritaki with eye exercises in management of Timir with reference to simple myopia. |
|
Scientific Title of Study
|
Clinical comparative study of efficacy of Haritaki as a single drug and Haritaki with eye exercise in management of Timir with special reference to Simple Myopia. |
| Trial Acronym |
-not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMADHURA SHARDUL BAPAT |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AVPMS AYURVED MAHAVIDYALAYA SION |
| Address |
Loknete Rajarambapu Patil Ayurved college ,Hospital and PG institute ,Islampur 415409
AVPMS AYURVED MAHAVIDYALAYA SION
SION RAILWAY COLONY SION WEST
MUMBAI 400022
Mumbai
MAHARASHTRA
415409
India |
| Phone |
9970772299 |
| Fax |
|
| Email |
madhurabapat18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ravidas More |
| Designation |
Associate professor |
| Affiliation |
AVPMS AYURVED MAHAVIDYALAYA SION |
| Address |
AVPMS AYURVED MAHAVIDYALAYA SION
SION RAILWAY COLONY SION WEST
MUMBAI 400022
AVPMS AYURVED MAHAVIDYALAYA SION
SION RAILWAY COLONY SION WEST
MUMBAI 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9967483930 |
| Fax |
|
| Email |
ravimore67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMADHURA SHARDUL BAPAT |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AVPMS AYURVED MAHAVIDYALAYA SION |
| Address |
Loknete Rajarambapu Patil Ayurved college ,Hospital and PG institute ,Islampur 415409
AVPMS AYURVED MAHAVIDYALAYA SION
SION RAILWAY COLONY SION WEST
MUMBAI 400022
Mumbai
MAHARASHTRA
415409
India |
| Phone |
9970772299 |
| Fax |
|
| Email |
madhurabapat18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Madhura Bapat PhD scholar S Loknete Rajarambapu Patil aAyurved Medical College and Hospital PG Institute Islampur 415409 |
|
|
Primary Sponsor
|
| Name |
Dr. Madhura Shardul Bapat |
| Address |
Loknete Rajarambapu Patil ayurvrdic medical college ,Hospital and Pg institute Islampur 415409 |
| Type of Sponsor |
Other [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 |
| DrMadhura Bapat |
AVPMS Ayurved Mahavidyalaya Sion |
Shalakyatantra Department ,Ayurved Prasarak Mandal Rd Sion Railway Colony Sion West Mumabai 400022
Mumbai
MAHARASHTRA |
9970772299
madhurabapat18@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:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: TIMIRAH, (2) ICD-10 Condition:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Haritali plus Eye-ecercises | Eye exercises like palming ,blinking ,figure eight ,20-20-20 rule | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritaki , Reference: Ashtang Hriday, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: -Mrudvika and jal), Additional Information: -- |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients between age group 18-25 yrs
2)Classical symptoms of Timir /pratham patalgat vikar
3)Patients with Spherical refractive error.
4)Refractive errors upto (-0.50 D) to (-3 D) |
|
| ExclusionCriteria |
| Details |
1)Patients with ocular dises like Glaucoma ,Retinal detachment or systemic diseases like type ii DM ,Asthama ,Hypo /hyper thyroidism
2)Patients having extra ocular & intra ocular infections like conjunctivitis,Blepharitis and Dacryocystitis
3)Patients having corneal ulcers
4)Patients after surgeries like photorefractive keratotomy,post-traumatic or congenital cataract surgery ,Radial keratotomy ,LASIK etc...
5)Patients practcing pranayama or daily exercises
6)Refractive errors more than -3D |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of Haritaki in management of Avyakt Darshan (blurring ),Headache ,Eyepain ,Redness ,Visual acuity . |
40 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of Haritaki as a single drug & Haritaki with eye exercises in management of Avyakt Darshan (blurring) ,Headache ,Eye pain & visual acuity |
40 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
10/08/2023 |
| 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 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
|
This is two group comparative study to evaluate the efficacy of Haritaki (1gm along with 8-10 mrudvika and water as anupan at morning ) (group 1 - 50 patients ) as single drug and Haritaki (1gm along with 8-10 mrudvika and water as anupan at morning )with eye exercises(15-20 min daily) (group 2 - 50 patients) for 40 days .Primary outcome is to study the effectiveness of Haritaki as single drug in management of Timir .Secondary outcome is to find out the role of Haritaki as single drug along with Mrudvika on sign and symptoms of Timir. |