| CTRI Number |
CTRI/2019/06/019777 [Registered on: 20/06/2019] Trial Registered Prospectively |
| Last Modified On: |
20/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectivness of Goghrita tarpan with and without Bibhitakadi Ghrit Abhyantar prayog in Myopia. |
|
Scientific Title of Study
|
A comparative clinical study of Goghrita tarpan with and without Bibhitakadi Ghrit Abhyantar prayog in the management of Myopia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogita Jadhav |
| Designation |
PG Student |
| Affiliation |
PDEAs College of Ayurveda and Research center |
| Address |
PDEAs College of Ayurveda and Research center Akurdi Sec no 25 Pune Ayurved Rugnalay and Sterling Multispeciality hospital Sec No 27 Nigdi Pune Ground Floor Shalakyatantra Department OPD No 122
Pune
MAHARASHTRA
411044
India |
| Phone |
9503130366 |
| Fax |
|
| Email |
dryogitajadhav2292@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandana Virkar |
| Designation |
HOD and Guide Dept of Shalakyatantra |
| Affiliation |
PDEAs College of Ayurveda and Research Center |
| Address |
PDEAs College of Ayurveda and Research center Akurdi Sec no 25 Pune Ayurved Rugnalay and Sterling Multispeciality hospital Sec No 27 Nigdi Pune Ground Floor Shalakyatantra Department OPD No 122
Pune
MAHARASHTRA
411044
India |
| Phone |
9822199107 |
| Fax |
|
| Email |
virkar.chandana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogita Jadhav |
| Designation |
PG Student |
| Affiliation |
PDEAs College of Ayurveda and Research center |
| Address |
PDEAs College of Ayurveda and Research center Akurdi Sec no 25 Pune Ayurved Rugnalay and Sterling Multispeciality hospital Sec No 27 Nigdi Pune Ground Floor Shalakyatantra Department OPD No 122
Pune
MAHARASHTRA
411044
India |
| Phone |
9503130366 |
| Fax |
|
| Email |
dryogitajadhav2292@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda and Research center 3rd floor Shalakya department Nigdi Pradhikaran Sec No 25 Pune 44 |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurveda and Research center |
| Address |
Sec No 25 Nigdi pradhikaran Pune 44 |
| 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 Yogita Jadhav |
Ayurved Rugnalay and Sterling Multispecialty Hospital |
Vitthal Rukmini road Sec No 27 Nigdi Pradhikaran Pune 411044
Depratment of Shalakyatantra OPD No 122 on ground floor
Pune
MAHARASHTRA |
9503130366
dryogitajadhav2292@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
Bibhitakadi Ghrit |
Bibhitakadi Ghrita explained in Yogratnakar netrarog chikitsa and prepared by standard method of Sharandhar Samhita. Bibhitakadi Ghrita abhyantar prayog 10 ml at night for 3 months with Goghrit tarpan. Goghrit Approximate 20 ml per day for Tarpana in the Morning
Duration - 1 sittings for 7 days each with 3 weeks interval (3 setting in 3 months)
|
| Comparator Agent |
Goghrit Tarpan |
Goghrit Approximate 20 ml per day for Tarpana in the Morning Duration - 1 sittings for 7 days each with 3 weeks interval (3 setting in 3 months) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of Myopia: Diminished Distant vision
Eyestrain,
Headache,
Watering of eyes
|
|
| ExclusionCriteria |
| Details |
Known Case of Congenital anomalies of eye, any other known ocular pathology, bacterial conjunctivitis, corneal pathology, High myopia with degenerative & retinal changes, any systemic disorders, underwent any of the refractive surgeries. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Goghrit Tarpan for consecutive 7 days in a month for 3 months with and without Bibhitakadi Ghrit abhyantar prayog for 3 months in the management of Myopia. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe adverse effect if any. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/06/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Nowadays Myopia is increased due to excess use of PC, smart phones, TV, study stress. In some cases family history, pathological conditions are responsible for that. In OPD about 30% patients are suffering from Myopia. Myopia is more in adolescent age group. Myopia means short sightedness. It is a type of refractive error in which parallel rays of light coming from infinity are focused in front of the retina when accommodation is at rest. In Ayurveda when we refer our classical texts for management of Timira, Sushrut and Vagbhata have told the use of various Kriyakalpas like Nasya, Anjana, Tarpana etc. |