| CTRI Number |
CTRI/2019/03/018035 [Registered on: 12/03/2019] Trial Registered Prospectively |
| Last Modified On: |
09/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [PANCHKARMA THERAPY OF NASYAM ANS TARPANA] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
AYURVEDIC MANAGEMENT OF SHORT SIGHT |
|
Scientific Title of Study
|
A CLINICO-COMPARATIVE STUDY ON EFFICACY OF NASYAM AND TARPANA WITH MAHATRIPHALADI GHRITA IN PRATHAMA PATALAGATA 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 |
SHUSHMITA RAVINDRA MOTADOO |
| Designation |
P.G SCHOLAR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVUM ANUSANDHAN SANSTHAN |
| Address |
OPD NO. 1 DEPARTMENT OF SHALAKYA TANTRA , PATANJALI AYURVEDA HOSPITAL, PATANJALI BHARTIYA AYURVIGYAN EVUM ANUSANDHAN SANSTHAN, HARIDWAR
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7304616461 |
| Fax |
|
| Email |
shushmitamotadoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PREETI PAHWA |
| Designation |
ASSISSTANT PROFESSOR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVUM ANUSANDHAN SANSTHAN |
| Address |
OPD NO. 1 DEPARTMENT OF SHALAKYA TANTRA , PATANJALI AYURVEDA HOSPITAL, PATANJALI BHARTIYA AYURVIGYAN EVUM ANUSANDHAN SANSTHAN, HARIDWAR
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9953117417 |
| Fax |
|
| Email |
drpreeti25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PREETI PAHWA |
| Designation |
ASSISSTANT PROFESSOR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVUM ANUSANDHAN SANSTHAN |
| Address |
OPD NO. 1 DEPARTMENT OF SHALAKYA TANTRA , PATANJALI AYURVEDA HOSPITAL, PATANJALI BHARTIYA AYURVIGYAN EVUM ANUSANDHAN SANSTHAN, HARIDWAR
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9953117417 |
| Fax |
|
| Email |
drpreeti25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurveda Hospital
PATANJALI BHARTIYA AYURVIGYAN EVUM ANUSANDHAN SANSTHAN, HARIDWAR |
|
|
Primary Sponsor
|
| Name |
PATANJALI AYURVED COLLEGE |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVUM 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 |
| SHUSHMITA MOTADOO |
PATANJALI AYURVED HOSPITAL |
OPD NO. 1 DEPARTMENT OF SHALAKYA TANTRA patanjali ayurvigyan evum anusandhan sansthan
Hardwar
UTTARANCHAL |
07304616461
shushmitamotadoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PAC/IEC/2017-18/19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EFFECT OF MAHATRIPHALADI GHRITA TARPANA IN MYOPIA |
PATIENTS WILL BE GIVEN TARPANA WITH MAHATRIPHALADI GHRITA FOR 7 DAYS |
| Comparator Agent |
EFFECT OF NASYAM WITH MAHATRIPHALADI GHRITA IN MYOPIA |
PATIENTS WILL BE GIVEN NASYA WITH JEEVANTYADI GHRITA FOR 7 DAYS |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with classical symptoms of timir/myopiA
2. Patients who are fit for nasya karma.
3. Patients who are fit for tarpana karma.
4. Patients with less than 6 D.
|
|
| ExclusionCriteria |
| Details |
1.Patients less than 8 yrs of age and above 35 years of age.
2.Patients suffering from any systemic diseases and receiving medicine.
3.Patients who are contraindicated for nasya and tarpana karma.
4.Patients with more than 6 D.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A). SUBJECTIVE :-
1) Headache 2) Watering of eyes
3) Blurred Vision 4) Pain in eyes
B). OBJECTIVE :-
1) Visual Acuity
2) Auto refraction examination for refractive errors.
|
Just Before intervention of nasyam and tarpan in myopia patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A). SUBJECTIVE :-
1) Headache 2) Watering of eyes
3) Blurred Vision 4) Pain in eyes
B). OBJECTIVE :-
1) Visual Acuity
2) Auto refraction examination for refractive errors. |
Immediately After intervention of nasyam and tarpan in myopia |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/03/2019 |
| 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
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this trial , we are selecting the patients of myopia in which we will do the intervention in two groups (30 patients in each group). In one group, we will intervene with ayurvedic therapy of Nasya with mahatriphaladi ghrita for 7 days, whereas in other group, we will intervene with ayurvedic therapy of tarpan with mahatriphaladi ghrita for 7 days. Assessment should be done on the basis of investigation done during pre-treatment and post-treatment as discussed earlier. |