| CTRI Number |
CTRI/2025/02/080823 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the efficacy of Triphaladi Yoga in the management of Dwitiya Patalgat Timir w.s.r. to Early Presbyopia |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Triphaladi Yoga in the management of Dwitiya Patalgat Timir w.s.r. to Early Presbyopia |
| 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 Sukhdev Singh |
| Designation |
Professor |
| Affiliation |
|
| Address |
Room no.- 210 Department of Shalakya Tantra, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola, Distt.Kangra, Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418471230 |
| Fax |
|
| Email |
drsukhdev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukhdev Singh |
| Designation |
Professor |
| Affiliation |
|
| Address |
Room no.-210 Department of Shalakya Tantra, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola, Distt.Kangra, Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418471230 |
| Fax |
|
| Email |
drsukhdev@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukhdev Singh |
| Designation |
Professor |
| Affiliation |
|
| Address |
Room no.-210 Department of Shalakya Tantra, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola, Distt.Kangra, Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418471230 |
| Fax |
|
| Email |
drsukhdev@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 H.P. |
|
|
Primary Sponsor
|
| Name |
Principal R.G.G.P.G. Ayurvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola, Distt.Kangra, Himachal Pradesh 176115 |
| 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 Sukhdev Singh |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
P.G. Deptt. of Shalakya Tantra, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola, Distt.Kangra, Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH |
9418471230
drsukhdev@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:H524||Presbyopia. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphaladi Yoga, Reference: Bhaishajya Ratnawali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Madhu and Ghrita), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphaladi Yoga, Reference: Bhaishajya Ratnawali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to undergo trial.
Patient presenting with signs and symptoms of Dwitiya Patalgat Timir (Early Presbyopia)
Age group between 35-40 years. |
|
| ExclusionCriteria |
| Details |
Patients not willing to undergo trial.
Patients suffering from Early Presbyopia associated with other ocular disease like trichiasis, ectropion, entropion, corneal ulcer, dacryocystitis,etc.
Patients suffering from any systemic/metabolic disorders i.e., cardiovascular diseases, diabetes, hypertension, anaemia. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study the efficacy of Triphaladi Yoga in the management of Dwitiya Patalgat Timir w.s.r.to Early Presbyopia |
Study the efficacy of Triphaladi Yoga in the management of Dwitiya Patalgat Timir w.s.r.to Early Presbyopia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To generate feeling of well being |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To evaluate the efficacy of Triphaladi Yoga in the management of Dwitiya Patalgat Timir w.s.r. to Early Presbyopia. 30 patients will be selected and divided into two groups. In one group patients will be managed byTripahaldi Yoga with Sukhoshanjal and in other group patients will be managed byTriphaladi Yoga with madhu and go-ghrita.
|