| CTRI Number |
CTRI/2019/05/019058 [Registered on: 10/05/2019] Trial Registered Prospectively |
| Last Modified On: |
24/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Vision Improvement in eyes with astigmatism by Ayurvedic treatment of Triphala Ghrita local application on eyes |
|
Scientific Title of Study
|
A Randomised Controlled Trial Of Triphala Ghrita Orally and Triphala Ghrita Netratarpana in Vataja Timira w.r.t.Corneal Astigmatism |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nutan Ravindra Radaye |
| Designation |
PhD Scholar |
| Affiliation |
Government Ayurved College and Hospital,Nagpur |
| Address |
OPD of Shalakyatantra
GAC Nagpur
Sakkardara Chowk Raje Raghuji Nagar Umred Road Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
09820512695 |
| Fax |
07122751007 |
| Email |
nutan.radaye.nr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nutan Ravindra Radaye |
| Designation |
PhD Scholar |
| Affiliation |
Government Ayurved College and Hospital,Nagpur |
| Address |
OPD of Shalakyatantra
GAC Nagpur
Sakkardara Chowk Raje Raghuji Nagar Umred Road Nagpur
MAHARASHTRA
440024
India |
| Phone |
09820512695 |
| Fax |
07122751007 |
| Email |
nutan.radaye.nr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hari Umale |
| Designation |
Professor |
| Affiliation |
Government Ayurved College and Hospital |
| Address |
OPD of Shalakyatantra
GAC Nagpur
Sakkardara Chowk Umred Road Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
09423682026 |
| Fax |
07122751007 |
| Email |
drumaleayurved@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra Goernment Ayurved college Nagpur |
|
|
Primary Sponsor
|
| Name |
Department of Shalakyatantra Government Ayurved College and Hospital Nagpur |
| Address |
Sakkardara Chowk Umred Road Raje Raghuji Nagar Nagpur 440024 |
| 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 Nutan Ravindra Radaye |
Government Ayurved College and Hospital |
OPD no.33 Department Of Shalakyatantra Government Ayurved Hospital Sakkardara Chowk Umred Road Raje Raghuji Nagar Nagpur 440024
Nagpur
MAHARASHTRA |
9820512695
07122751007
nutan.radaye.nr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H522||Astigmatism, (2) ICD-10 Condition: H538||Other visual disturbances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Triphala Ghrita
Spectacle Number |
Triphala Ghrita will be prepared at GMP certified pharmacy Total 88 patients will be divided in 4 groups of 22 patients each
Group A spectacle number will be given
Group B spectacle number and Triphala Ghrita 20 ml orally at bed time for 30 days will be given
Group C Spectacle number and Triphala Ghrita Netratarpana 3 sittings for 5 days with a gap of 5 days for 30 days wii be given
Group D Spectacle number Triphala Ghrita 20 ml orally at bedtime and Triphala Ghrita Netratarpana 3 sittings of 5 days with a gap of 5 days for 30 days will be given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients within age group 18 yrs to 35 with symptoms of Vataja Timira (Corneal Astigmatism) attending OPD of study centers and giving valid informed consent will be included
Symptoms are -
Aavila Darshana (Diminished Vision)
Arunabha Darshana(Slightly reddish looking objects)
Vyaviddha Darshana (Distorted visual perception)
Bhramativa Darshana (Haloes)
Headache (frontal & brow)
Eye strain
Watering from eyes
2) Patients with corneal astigmatism more than +/- 0.75 D and less than +/- 5.0 D |
|
| ExclusionCriteria |
| Details |
1) Patients below 18 yrs.
and above 35 yrs
2) Patients having ocular diseases causing astigmatism like Cataract, Keratoconus,
SPK, Pterygium, Glaucoma, Retinal diseases and any ocular surgery.
3) Patients having corneal diseases like Corneal Ulcer, Opacity, and Dystrophy.
4) Patients with systemic diseases like diabetes, Hypertension and
Immunocompromised patients
5) Pregnant and Lactating mothers
6) Patients with Lenticular Astigmatism & Corneal Astigmatism less than +/- 0.75 D and more than
+/- 5.0 D |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the Corneal curvature corneal thickness astigmatism power improvement in symptoms of Vataja Timira |
88 patients will be divided in 4 groups of 22 patients each and Triphala Ghrita Orally and Netratarpana given for 30 days Patients assesed before and after treatment Total duration will be 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms of Corneal Astigmatism |
88 patients will be divided in 4 groups of 22 patients each and Triphala Ghrita Orally and Netratarpana given for 30 days Patients assesed before and after treatment Total duration will be 24 months |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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 4 |
|
Date of First Enrollment (India)
|
01/07/2019 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is Randomised controlled Trial of Triphala Ghrita Orally and Triphala Ghrita Netratarpana in Vataja Timira ( Corneal Astigmatism ) In this study 88 patients will be divided in 4 groups Group A Spects number will be given Group B Spects number + Triphala Ghrita 20 ml orally will be given for 30 days Group C Spect number + Triphala Ghrita Netratarpana for 5 days sitting and gap of 5 days for 30 days Group D Spects number + Triphala Ghrita orally + Triphala Ghrita Netratarpana 5 days with a gap of 5 days for 30 days will be given Corneal Topography and Corneal Pachymetry will be used for assessment criteria Primary outcome will be change in Corneal Curvature Corneal Thickness Astigmatism power and Improvement in symptoms of Vataja Timira like Avila Darshana Arunabha Darshana Vyaviddha Darshana Bhramativa Darshana |