| CTRI Number |
CTRI/2019/09/021470 [Registered on: 30/09/2019] Trial Registered Prospectively |
| Last Modified On: |
27/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to see the effect of ayurvedic drug in the management of Shushkakshipaka w.s.r. to dry eye syndrome |
|
Scientific Title of Study
|
A randomized clinical Study to evaluate Mahoushadha Anjana and Shamana Snehapana in the management of Shushkakshipaka w.s.r.to dry eye syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajendra Kumar Soni |
| Designation |
Lecturer |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Shalakya Tantra,National Institute of Ayurveda,Jaipur,near Jorawer Singh Gate,Madhav Vilas,Amer Road jaipur
P.G. Department of Shalakya Tantra,National Institute of Ayurveda,Jaipur,near Jorawer Singh Gate,Madhav Vilas,Amer Road jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7017970757 |
| Fax |
|
| Email |
vaidya.rajsoni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Kumar Soni |
| Designation |
Lecturer |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Shalakya Tantra,National Institute of Ayurveda,Jaipur,near Jorawer Singh Gate,Madhav Vilas,Amer Road jaipur
P.G. Department of Shalakya Tantra,National Institute of Ayurveda,Jaipur,near Jorawer Singh Gate,Madhav Vilas,Amer Road jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7017970757 |
| Fax |
|
| Email |
vaidya.rajsoni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raj Kumar Sharma |
| Designation |
P.G. Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Shalakya Tantra,National Institute of Ayurveda,Jaipur,near Jorawer Singh Gate,Madhav Vilas,Amer Road jaipur
P.G. Department of Shalakya Tantra,National Institute of Ayurveda,Jaipur,near Jorawer Singh Gate,Madhav Vilas,Amer Road jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9887393772 |
| Fax |
|
| Email |
dr.dorwalayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda,Jaipur,Rajasthan,302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
P.G. Department of Shalakya Tantra,National Institute of Ayurveda,Jaipur |
| 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 Rajendra Kumar Soni |
National Institute of Ayurveda, Jaipur |
OPD no.14, P.G. Department of Shalakya Tantra,Jaipur,Rajasthan,302002
Jaipur
RAJASTHAN |
7017970757
vaidya.rajsoni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H05||Disorders of eyelid, lacrimal system and orbit, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Carboxy methyl cellulose sodiun eye drops |
Carboxy methyl cellulose sodiun (CMC) eye drops.
1-1 drops four times a day local application |
| Intervention |
shunt Powder with Erandbrashtaharitaki
mahoushadha Anjana with Triphala Ghritta |
Shunti Power 1.5 gm twice a day with luke warm water for 5 days and Erandbrashtaharitaki 4 gm once at night with luke warm water for 5 days.
Mahoushadha Anjana 0.050 mg once at evening time for 30 days for local application and
Triphala Ghritta 20 ml once in morning for 30 days orally |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms of shushkakshipaka described as per Ayurveda and mordern parlance |
|
| ExclusionCriteria |
| Details |
1.Severe cases of dry eye with complication like perforated corneal ulcer, Uveitis, Glaucoma
2.Inflammatory conditions like Acute Conjunctivitis etc
3.Patients with severe systemic illness
4.Pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Mahoushadha Anjana with Triphala Ghrita in the management of Shushkakshipaka(DES) |
1 months 15days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Any adverse event reported voluntarily,observed or enquired.
Recurrence in sign and symptoms of Shushkakshipaka(DES) |
1 months 15days |
|
|
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 1 |
|
Date of First Enrollment (India)
|
01/10/2019 |
| 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="0"
Months="1"
Days="15" |
|
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)?
|
|
Brief Summary
|
The study will be a randomised clinical phase 1 trial. The screened patients will be randomly divided in two groups using computerized randomization method for unbiased allocationGROUP A : Patients will be treated with Shunti powder and Erandbrashtaharitaki for Deepana pachana for 5 days. After 5 days will be treated with Mahoushadha Anjana for local application along with Triphala ghritta orally intake for 30 days.
GROUP B : Patients will be treated with Carboxy Methyl Cellulose sodium (CMC) eye drops , 1 drops four times a day
Aims and Objectives : 1.To study Shushkakshipaka in both Ayurveda and mordern parlance 2.To evaluate the efficacy of Mahoushadha Anjana and Triphala ghritta on Shushkakshipaka clinically 3.To compare the efficacy of trial drugs
|