| CTRI Number |
CTRI/2021/07/034999 [Registered on: 20/07/2021] Trial Registered Prospectively |
| Last Modified On: |
16/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the evaluation of medicine given through
two routes.Mahatriphaladi ghrita and go-ghtita locally in eyes,saptamrit lauh and amalaki rasayan orally in myopia. |
|
Scientific Title of Study
|
“EVALUATION
OF MAHATRIPHALADI GHRITA AND GO- GHRITA,
TARPANA WITH AMALAKI RASAYANA AND
SAPTAMRIT LAUH ORALLY IN PRATHAMA
PATALAGATA TIMIRA(MYOPIA).
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jasmine kaur |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bharatiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand |
| Address |
OPD No-1 Shalakya tantra department Patanjali Bharatiya Ayurvigyan Evam Anusandhan Sansthan,Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8295809007 |
| Fax |
|
| Email |
Jas050592@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Daya Shankar Singh |
| Designation |
Associate professor |
| Affiliation |
Patanjali Bharatiya Ayurvigyan Evam Anusandhan Sansthan Haridwar ,Uttarakhand |
| Address |
OPD No-1 Shalakya tantra department Patanjali Bharatiya Ayurvigyan Evam Anusandhan Sansthan,Haridwar
OPD No-1 Shalakya tantra department Patanjali Bharatiya Ayurvigyan Evam Anusandhan Sansthan,Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8194028515 |
| Fax |
|
| Email |
dayaayush@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Daya Shankar Singh |
| Designation |
Associate professor |
| Affiliation |
Patanjali Bharatiya Ayurvigyan Evam Anusandhan Sansthan Haridwar ,Uttarakhand |
| Address |
OPD No-1 Shalakya tantra department Patanjali Bharatiya Ayurvigyan Evam Anusandhan Sansthan,Haridwar
OPD No-1 Shalakya tantra department Patanjali Bharatiya Ayurvigyan Evam Anusandhan Sansthan,Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8194028515 |
| Fax |
|
| Email |
dayaayush@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bharatiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Patanjali Bharatiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand |
| Address |
OPD No-1 Shalakya tantra department Patanjali Bharatiya Ayurvigyan Evam Anusandhan Sansthan,Haridwar |
| 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 |
| Jasmine kaur |
PATANJALI AYURVEDIC HOSPITAL |
OPD No-1 Shalakya tantra department Patanjali Bharatiya Ayurvigyan Evam Anusandhan Sansthan,Haridwar
Hardwar
UTTARANCHAL |
8295809007
Jas050592@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Patanjali Ayurvedic college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: Pratham patalagata Timira(simple myopia), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saptamrita lauh, Reference: Bhaishajya ratnawali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 30(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ghrita), Additional Information: Dose - 5-16 yrs = 500 mg, >16yrs = 1gm a day
| | 2 | Intervention Arm | Procedure | - | 27. netratarpaNam नेmतप.णमॠPradhan Karma | (Procedure Reference: sushruta samhita, Procedure details: Tarpana with Go-ghrita and Mahatriphaladighrita
Dose: As per required Tarpana (up to sinking of eye lashes)
Duration: 800 to 1000 matra kala (max.25 min)
Time: Every morning for 7 days.)
(1) Medicine Name: mahatriphala ghrita, Reference: bhaishajya ratnawali, Route: Ocular, Dosage Form: Ghrita, Dose: 1(NA), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are fit for Tarpana Karma.
Patients with low myopia(≤ -3D Sph) |
|
| ExclusionCriteria |
| Details |
Patients who are contraindicated for Tarpana Karma.
Patients with other eye diseases like retinal degeneration, high myopia etc. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE PARAMETERS:
Vihphala Darshana / Blurred vision
Shiroabhitapa / Headache
Netrasrava / Watering of eyes
Netrayasa / Strain in eyes.
OBJECTIVE PARAMETERS:
Visual acuity (ETDRS Chart/ Log MAR Chart)
Auto-refraction/ Subjective refraction Examination for refractive errors
Keratometry |
Before intervention of tarpana with mahatriphala ghrita and go ghrita with oral intake of amalaki rasayan and saptamrit lauh |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE PARAMETERS:
Vihphala Darshana / Blurred vision
Shiroabhitapa / Headache
Netrasrava / Watering of eyes
Netrayasa / Strain in eyes.
OBJECTIVE PARAMETERS:
Visual acuity (ETDRS Chart/ Log MAR Chart)
Auto-refraction/ Subjective refraction Examination for refractive errors
Keratometry |
After intervention of tarpana with mahatriphala ghrita and go ghrita with oral intake of amalaki rasayan and saptamrit lauh. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
21/07/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this trial we are selecting patients of prathama patalagata Timira (simple myopia)in which we will do the intervention in two groups that means in group A-20 patients and group B20 patients,we will intervent with Ayurvedic therapy of tarpana with mahatriphala ghrita in GROUP A and go ghrita in GROUP B and oral medicines (saptamrit lauh and amalaki rasayan) in both groups respectively for 30 days (2sittings). Assessment will be done on the basis of investigation before and after treatment. |