| CTRI Number |
CTRI/2023/09/058100 [Registered on: 27/09/2023] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know the effect of Timirhar lauha on vision. |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Timirhar lauha on Visual acuity. |
| 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 Satish Sharma |
| Designation |
Reader P.G.Department of Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic Medical College And Hospital, Paprola |
| Address |
Department of Shalakya Tantra , Rajiv Gandhi Government Post
Graduate Ayurvedic College And Hospital Paprola , Distt Kangra
,Himachal Pradesh,176115 ,India
Rajiv Gandhi Government Post Graduate Ayurvedic Medical College And Hospital, Paprola , Distt. Kangra, Himachal Pradesh ,176115 India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
09418073368 |
| Fax |
|
| Email |
drsatishsharma.ods@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish sharma |
| Designation |
Reader P.G.Department of Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic Medical College And Hospital, Paprola |
| Address |
Department of Shalakya Tantra , Rajiv Gandhi Government Post
Graduate Ayurvedic College And Hospital Paprola , Distt Kangra
,Himachal Pradesh ,176115 India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
09418073368 |
| Fax |
|
| Email |
drsatishsharma.ods@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nivedita Thakur |
| Designation |
PG SCHOLAR |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic Medical College And Hospital, Paprola |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic Medical College And Hospital, Paprola .
Rajiv Gandhi Government Post Graduate Ayurvedic Medical College And Hospital, Paprola .
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
09876255301 |
| Fax |
|
| Email |
niveditathakur360@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 |
Rajiv Gandhi Government Post Graduate Ayurvedic Medical College And Hospital, Paprola , Distt. Kangra, Himachal Pradesh ,176115 India |
| 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 |
| DrSatish Sharma |
R.G.G.P.G. Ayurvedic college and hospital ,paprola |
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, India.
Kangra
HIMACHAL PRADESH |
9418073368
drsatishsharma.ods@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H525||Disorders of accommodation. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Timirhar lauha, Reference: Bhaishjya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 50(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Timirhar lauha, Reference: Bhaishjya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 50(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -shukoushan jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients willing for trial.
b. Patients having refractive error with normal ophthalmoscopic findings
c. Patients betweenages of 19 to 50 year.
d. Patients having no other ocular disease and systemic disease.
|
|
| ExclusionCriteria |
| Details |
a. Patients not willing for trial.
b. Patients below 19 years and above 50 years of age.
c. Patients having lenticular changes and ocular diseases like - Glaucoma, cataract, corneal opacity, corneal ulcer, Age related macular degeneration, uveitis, stye, Trichiasis, diabetic retinopathy, strabismus etc.
d. Associated symptoms i.e. fever, malaise and lymphadenopathy.
e. Patients having systemic disorders i.e. Cardio vascular disorder, Diabetes and hypertension
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| i.To study the efficacy of Timirhar lauhaon visual acuity. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| generate feeling of well being. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2023 |
| Date of Study Completion (India) |
18/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
To evaluate the effect of Timirhar lauha on Visual acuity. 30 patients will be selected and divided into two groups. In one group patients having Timirhar lauha with madhu and other group the patients having Timirhar lauha with Sukhoshan jala. Then before after effect of drug on visual acuity will be studied. |