| CTRI Number |
CTRI/2023/04/051838 [Registered on: 21/04/2023] Trial Registered Prospectively |
| Last Modified On: |
20/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Evaluate the effect of Madhukadi Lauha in Timir w.s.r. to Myopia |
|
Scientific Title of Study
|
A Clinical study to Evaluate the effect of Madhukadi Lauha in Timir w.s.r. to Myopia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sukhdev Singh |
| Designation |
Sr. Lecturer, M.S. (Ayu.) Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P. |
| Address |
Room No. 210,Anatomy block RGGPG Ayurvedic College and Hospital Paprola, Kangra. (H.P.)
OPD 219 RGGPG Ayurvedic College and Hospital Paprola, Kangra. (H.P.)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418471230 |
| Fax |
|
| Email |
drsukhdev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukhdev Singh |
| Designation |
Sr. Lecturer, M.S. (Ayu.) Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P. |
| Address |
Room No. 210,Anatomy block RGGPG Ayurvedic College and Hospital Paprola, Kangra. (H.P.)
OPD 219 RGGPG Ayurvedic College and Hospital Paprola, Kangra. (H.P.)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418471230 |
| Fax |
|
| Email |
drsukhdev@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanisha Pathania |
| Designation |
PG Scholar |
| Affiliation |
R. G. G. P. G. Ayurvedic College & Hospital Paprola, Kangra. (H.P.) |
| Address |
RGGPG Ayurvedic College and Hospital Paprola, Kangra. (H.P.)
OPD 219 RGGPG Ayurvedic College and Hospital Paprola, Kangra. (H.P.)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8628868287 |
| Fax |
|
| Email |
tanishapathania41@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy, Paprola, Distt. Kangra, H.P.
Charak Pharmacy, RGGPG Ayurvedic College, Paprola, Kangra
Research institute in I.S.S.M. Jogindernagar, H.P. |
|
|
Primary Sponsor
|
| Name |
Principal, RGGPG Ayurvedic College& Hospiyal Paprola, Kangra |
| Address |
RGGPG Ayurvedic College & Hospital Paprola, Kangra |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sukhdev Singh |
RGGPG Ayurvedic College & Hospital, Paprola, Kangra |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sukhdev Singh |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra. |
OPD 219 RGGPG Ayurvedic College and Hospital, Paprola, Kangra
Kangra
HIMACHAL PRADESH |
9418471230
drsukhdev@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee RGGPG Ayurvedic College and Hospital, Paprola, Kangra. |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Madhukadi Lauha, Reference: Bhaishjya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: water), Additional Information: follow up after 15 days till completion of trial. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madhukadi Lauha, Reference: Bhaishjya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ghrita 2g and Madhu 1g), Additional Information: follow up after 15 days till completion of trial.
Delete |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing for trial.
b. Patients having Myopia with normal ophthalmoscopic findings. |
|
| ExclusionCriteria |
| Details |
a. Patients not willing for trial.
b. Patients below 8 years and above 30 years of age.
c. 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.
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
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improved distant vision on Snellens chart. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| feeling of well being |
30 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/04/2023 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Twenty patients fulfilling the inclusion criteria will be selected and divided into two groups. Both the groups of patients will be treated with Madhukadi Lauha with different anupan. The outcome will be analysed with appropriate statistical tools. |