| CTRI Number |
CTRI/2024/06/069643 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role of Triphala ghrita and Drishtivardhak nasya in the management of Pratham patal gata timir or Myopia |
|
Scientific Title of Study
|
A Comparative study of combined effect of Triphala ghrita as paan with Drishtivardhak nasya and Akshitarpan with Drishtivardhak nasya in the management of Pratham patal Timira wsr to simple myopia |
| 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 Pranjali Priya |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Ayurvedic College Kadamkuan Patna |
| Address |
Department of Shalakya tantra
Government Ayuervedic College Kadamkuan Patna
Patna BIHAR 800003 India |
| Phone |
7070373649 |
| Fax |
|
| Email |
pranjalipriya93@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prof Ajay Kumar Singh |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College Kadamkuan Patna |
| Address |
Department of Shalakya Tantra
Government Ayurvedic College
Kadamkuan Patna
Patna BIHAR 800003 India |
| Phone |
9576952168 |
| Fax |
|
| Email |
dr.aksingh969@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prof Ajay Kumar Singh |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College Kadamkuan Patna |
| Address |
Department of Shalakya Tantra
Government Ayurvedic College
Kadamkuan Patna
Patna BIHAR 800003 India |
| Phone |
9576952168 |
| Fax |
|
| Email |
dr.aksingh969@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College
Kadamkuan Patna 800003 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic College Health Department Government of Bihar |
| Address |
Government Ayurvedic College and Hospital Kadamkuan Patna
800003 |
| Type of Sponsor |
Government 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 Prof Ajay Kumar Singh |
Government Ayurvedic College And Hospital Patna |
Room no 02
Department of Shalakya Tantra Patna BIHAR |
9576952168
dr.aksingh969@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Approval of Institutional ethical committee , Government Ayurvedic College Hosptal Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala Ghrita, Reference: Ashtang Hridaya Uttar Sthan 13, Route: Oral, Dosage Form: Ghrita, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ashtang Hridaya Uttar Sthan 13, Procedure details: Nasya will be done with 10 drop Drishtivardhak nasya in every morning for 7 days regularly. This procedure will be done for 4 months.) (1) Medicine Name: Triphala Ghrita, Reference: Ashtang Hridaya Uttar Sthan 13, Route: Ocular, Dosage Form: Ghrita, Dose: 30(g), Frequency: od, Duration: 4 Months |
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having Simple Myopia up to -1.0D
2.Patient having lakshanas of Pratham Patalgata Doshadushti. |
|
| ExclusionCriteria |
| Details |
1.Patient having myopia more than -1.0D
2.Patient having ocular diseases other than simple myopia
3.Patient having any systemic diseases
4.Patient having post operative myopia |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcomes are -
1. Refractive error
2.Visual acuity
3. Dimness vision
4. Blurred vision
5. Eye strain
6.Headache
7.Watering of eye
8.Redness of eye
|
120 days (4 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcomes are -
1.Refractive error
2.Visual acuity
3. Dimness vision
4. Blurred vision
5. Eye strain
6.Headache
7.Watering of eye
8.Redness of eye
|
3 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="0" Months="4" 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
|
Myopia is a major health
issue around the world. the World Health Organization estimates that half of
the population of the world may be myopic due to excess use of electronic gadgets.
In December 2019, a novel coronavirus rapidly spread in China and around the
world. The Govt started a nationwide school, college, office closure people do
their work in home with many types of gadgets such as laptop, mobile, computer
etc. During covid 19 the school-aged children were confined to their home and
online courses were offered. By which simple myopia were more developed, a number
patient was coming with DOV complain. In the management of myopia modern
science recommended proper corrected glasses contact lenses and refractive
surgery, they give relief but when people wear glasses and contact lenses, they
are feeling uncomfortable improper contact lenes wearing unhygienic conditions
orient the corneal pathology that is epithelial erosion, keratitis etc.Refractive
surgery is too much costly every person does not effort it. In our classics there are number of
formulation and different administration of drugs for the management of Timir. I
have selected the topic Pratham Patal Timir, so I would like to establish the
research classical formula of a drugs for the management of Pratham Patal gat
timir. We will have to make get rid of glasses, contact
lenes, and refractive surgery. As many patients of simple myopia visit our opd We felt need to develop a treatment that cause better cure with no or
lesser side effects, also we tried to choose the kind of drug that is easily available,
safe and cost effective under the guidance of best faculties. To see the comparative effect rate of
Triphla ghrita as paan with drishti vardhak nasya and akshitarpan with drishti
vardhak nasya, both group in the management of simple myopia. |