| CTRI Number |
CTRI/2017/05/008552 [Registered on: 15/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
09/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study on Combined Effectiveness of Oral and Topical Application of an Ayurvedic Medicine - Agastya Ghrita in the Management of Retinitis Pigmentosa |
|
Scientific Title of Study
|
An open label single arm clinical study on the effectiveness of agastya ghrita pana and tarpana in the management of shleshmavidagdha drishti
(retinitis pigmentosa).
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pushpa Raj Poudel |
| Designation |
PG scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Shalakya Tantra
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM Road
Thanniruhalla
Hassan 573201
Karnataka
India
Hassan
KARNATAKA
573201
India |
| Phone |
9035906765 |
| Fax |
|
| Email |
pundanraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushpa Raj Poudel |
| Designation |
PG scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Shalakya Tantra
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM Road
Thanniruhalla
Hassan 573201
Karnataka
India
KARNATAKA
573201
India |
| Phone |
9035906765 |
| Fax |
|
| Email |
pundanraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeraj B C |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Shalakya Tantra
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM Road
Thanniruhalla
Hassan 573201
Karnataka
India
Hassan
KARNATAKA
573201
India |
| Phone |
919964242466 |
| Fax |
|
| Email |
dheerateju.ayur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM Road
Thanniruhalla
Hassan 573201
Karnataka
India |
| Type of Sponsor |
Private 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 Pushpa Raj Poudel |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Room No 10 Eye OPD Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM Road
Thanniruhalla
Hassan 573201
Karnataka
India
Hassan
KARNATAKA |
9035906765
pundanraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics Committee Sri Dharmastahala Manjunatheshwara colleg of Ayurveda And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Shleshma vidagdha Drishti( Retinitis pigmentosa), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agastya Ghrita |
Agastya ghrita will be given for oral intake of one teaspoonful twice a day for period of one month.
Tarpana karma will be done with Agastya Ghrita once a day for two sitting. One sitting will be of seven days. Next sitting will be done after 14 days of first sitting. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient ready to sign in informed consent form irrespective of sex, and religion. Naktandhata (night blindness)
2. Difficulty in dark adaptation
3. Reduced field of vision
4.Blurredness of vision
5.Visual acuity test revealing reduced visual acuity.
6.Perimetry showing peripheral visual field defect
7. Opthalamoscopic evaluation of Fundus revealing classical triad of Retinitis pigmentosa (arteriolar attenuation, retinal bone-spicule pigmentation and waxy pallor).
8. Pictorial assessment of Retinitis pigmentosa through Fundal photograph |
|
| ExclusionCriteria |
| Details |
1.Patients having total blindness.
2.Patient with all kind of diabetic retinopathy and diabetic maculopathy.
3.Patient with pregnancy and lactating period
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in nightblindness
improvement in dark adaptation
improvement of field of vision
Visual acuity test revealing visual acuity improving
Perimetry showing peripheral visual field changes
Fundal pictorial changes
|
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| it checks the further deterioration of nightblindness, reduced peripheral visual field and blurredness of vision. |
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/03/2017 |
| 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) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a non randomized single arm clinical trial assessing the effectiveness of Agastya ghrita pana and Tarpana in the management of Shleshmavidagdha Drishti( Retinitis pigmentosa). 30 patients will be enrolled for this study for one month.This study period will be one and half year.The primary outcome measures will be reduction of night blindness, reduction of peripheral visual field loss and blurredness of vision. The secondary out come will be controls of the further deterioration of night blindness, reduced peripheral visual field and blurredness of vision. Baseline data will be assessed after the treatment and in first follow up after treatment i.e 45th and 60th day of treatment. |