| CTRI Number |
CTRI/2024/12/077673 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Triphala Kwatha with Goghrita in the management of Prathama Patalgata Timira(progressive myopia)in adults 15 to 30yrs |
|
Scientific Title of Study
|
Efficacy of Triphala Kwatha with Goghrita in the management of Prathama Patalgat Timira(progressive myopia)in adults 15 to 30yrs: Intervention study |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asmita Deogade |
| Designation |
PG scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya Nagpur |
| Address |
OPD NO 11 Shalakya tantra department Pakwasa Rugnalaya Shri Ayurved Mahavidyalaya Dhanwantari Marg Hanuman Nagar Nagpur 440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9130471930 |
| Fax |
|
| Email |
asmitadeogade21.ad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Govind Tundalwar |
| Designation |
HOD and associate Professor |
| Affiliation |
Shri Ayurved Mahavidyalaya Nagpur |
| Address |
OPD NO 11 Shalakya tantra department Pakwasa Rugnalaya Shri Ayurved Mahavidyalaya Dhanwantari Marg Hanuman Nagar Nagpur 440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9860166089 |
| Fax |
|
| Email |
drgovind2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asmita Deogade |
| Designation |
PG scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya Nagpur |
| Address |
OPD NO 11 Shalakya tantra department Pakwasa Rugnalaya Shri Ayurved Mahavidyalaya Dhanwantari Marg Hanuman Nagar Nagpur 440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9130471930 |
| Fax |
|
| Email |
asmitadeogade21.ad@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO 11 Shalakya tantra department Pakwasa Rugnalaya Shri Ayurved Mahavidyalaya Dhanwantari Marg Hanuman Nagar Nagpur 440024 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Asmita Suryabhan Deogade |
| Address |
OPD NO 11 Shalakya tantra department Pakwasa Rugnalaya Shri Ayurved Mahavidyalaya Dhanwantari Marg Hanuman Nagar Nagpur 440024 Maharashtra India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Asmita Suryabhan Deogade |
Shri Ayurved Mahavidyalaya Nagpur |
OPD NO 11 Shalakya tantra department Pakwasa Rugnalaya Shri Ayurved Mahavidyalaya Dhanwantari Marg Hanuman Nagar Nagpur 440024 Maharashtra India
Nagpur
MAHARASHTRA |
9130471930
asmitadeogade21.ad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of Shri Ayurved Mahavidyalaya Nagpur |
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 quath with Goghrut , Reference: Yogratnakar,, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Goghrut ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patient having classical symptoms of progressive myopia.
Age Group Between 15 to 30 years.
Patient of male and female. |
|
| ExclusionCriteria |
| Details |
Patients not willing for clinical trial.
Patients suffering from other systemic disorders.
Patients of pathological myopia associated with any severe condition will be excluding from study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To see the positive effect in reduction of dioptric power
2.To evaluate the efficacy of TRIPHALA KWATHA WITH GOGHRITA in the management of pratham patalgat timir (progressive myopia) in adults 15 to 30 yrs. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/12/2024 |
| 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="1"
Months="6"
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
|
A consecutive samples of 30 subjectswho are seeking treatment and care at the study hospital, who fulfil the eligibility (inclusion and exclusion) criteria and who consent to participant will be selected by convenience sampling method from the study setting (i.e.the OPD/Ward,/Hospital…) The improvement in the patients was assessed mainly on the basis of relief in sign and symptoms of the progressive myopia. For this purpose, the main signs and symptoms were given a Gradations according to their severity and all the parameters of assessment before, after and at follow up day was taken into consideration to assess the total effect of the treatment.
|