| CTRI Number |
CTRI/2023/02/050105 [Registered on: 27/02/2023] Trial Registered Prospectively |
| Last Modified On: |
24/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know the effect of triphala kwath and Go Ghrita on vision |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Effect of Triphala Kwath and Go Ghrita on Visual Acuity
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeev awasthi |
| Designation |
Professor and H.O.D. P.G.Deptt. of Shalakya Tantra |
| Affiliation |
R. G. G. P. G. Ayurvedic College and Hospital Paprola, Kangra. 176115 (H.P.) |
| Address |
Room no. 213 P.G.Deptt. of Shalakya Tantra first floor anatomy block R.G.G.P.G Ayurvedic College and Hospital Paprola Kangra. 176115 (H.P.)
OPD no. 219 R.G.G.P.G. ayurvedic college and hospital paprola kangra 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8261956005 |
| Fax |
01894242064 |
| Email |
drsanjeevawasthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev awasthi |
| Designation |
Professor and H.O.D. P.G.Deptt. of Shalakya Tantra |
| Affiliation |
R. G. G. P. G. Ayurvedic College and Hospital Paprola, Kangra. 176115 (H.P.) |
| Address |
Room no. 213 P.G.Deptt. of Shalakya Tantra first floor anatomy block R.G.G.P.G Ayurvedic College and Hospital Paprola Kangra. 176115 (H.P.)
OPD no. 219 R.G.G.P.G. ayurvedic college and hospital paprola kangra 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8261956005 |
| Fax |
01894242064 |
| Email |
drsanjeevawasthi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharti Parihar |
| Designation |
P. G. Scholar |
| Affiliation |
R. G. G. P. G. Ayurvedic College and Hospital Paprola, Kangra. 176115 (H.P.) |
| Address |
R.G.G.P.G Ayurvedic College and Hospital Paprola Kangra. 176115 (H.P.)
OPD no. 219 R.G.G. P. G. Ayurvedic College and Hospital Paprola Kangra. 176115 (H.P.)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
07869925278 |
| Fax |
|
| Email |
bhariparihar7050@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath pharmacy , Paprola ,District Kangra , Himachal Pradesh Charak pharmacy, R.G.G.P.G
Ayurvedic college , Paprola , Kangra Research institute in I.S.M Jogindernagar , Himachal pradesh |
|
|
Primary Sponsor
|
| Name |
Principal R.G.G.P.G ayurvedic college and hospital Paprola |
| Address |
R.G.G.P.G ayurvedic college and hospital Paprola |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sanjeev Awasthi |
R.G.G.P.G ayurvedic college and hospital Paprola |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSanjeev Awasthi |
R.G.G.P.G Ayurvedic college and Hospital paprola |
Room no.213 Department of Shalakya Tantra, Anatomy Block R.G.G.P.G.Ayurvedic college and Hospital paprola Kangra
Kangra
HIMACHAL PRADESH |
8261956005
01894242064
drsanjeevawasthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| EC Human RGGPG AyurvedicEC Human RGGPG Ayurvedic College Paprola College Paprola |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, (2) ICD-10 Condition: H520||Hypermetropia, , |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala kwath, Reference: Yog ratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Go ghrita), Additional Information: Triphala has various effects on vision in this group we will see the effect of triphala on MYOPIC patients | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala kwath, Reference: Yog ratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -Go Ghrita), Additional Information: -Triphala has various effects on vision in this group we will see the effect of triphala on HYPERMETROPIC patients |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing for trial.
Patients having refractive error with normal ophthalmoscopic findings
Patients between age of 19 to 50 year.
Patients having no other ocular disease and systemic disease. |
|
| ExclusionCriteria |
| Details |
Patients not willing for trial.
Patients below 19 years and above 50 years of age.
Patients having lenticular changes and ocular diseases like - Glaucoma, Cataract, Corneal Opacity, Corneal Ulcer, Age related macular degeneration, Uveitis, Stye, Triachiasis, Diabetic retinopathy, Strabismus etc.
Associated symptoms i.e. fever, malaise and lymphadenopathy.
Patients having systemic disorders i.e. Cardio vascular disorder, Diabetes and hypertension. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
to evaluate the effect of Triphala Kwath and Go Ghrita on visual acuity.
|
4 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| generate feeling of wellbeing |
1 month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2023 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To assess the efficacy of Triphala Kwath and Go Ghrita on the visual acuity. Twenty patients will be selected and divided into two groups. In one group patients having Myopia will be treated and in other group the patients having Hypermetropia both will be treated with triphala kwath and go ghrita. Then before after effect of drug on visual acuity will be studied |