| CTRI Number |
CTRI/2020/06/025511 [Registered on: 01/06/2020] Trial Registered Prospectively |
| Last Modified On: |
31/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A CLINICAL STUDY ON SHWETHA PALANDU EYE DROP IN THE MANAGEMENT OF IMMATURE CATARACT |
|
Scientific Title of Study
|
A TWO ARM RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED CLINICAL STUDY ON ANTI- CATARACT EFFECT OF SHWETHA PALANDU EYE DROP IN THE MANAGEMENT OF KAPHAJA TIMIRA (IMMATURE CATARACT) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR DIVYA STUVERT |
| Designation |
M.S (Ayu), ASSISTANT PROFFESOR, |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESWARA INSTTUTE OF AYURVEDA AND HOSPITAL, BANGALORE. |
| Address |
DEPARTMENT OF SHALAKYA TANTRA,SRI DHARMASTHALA MANJUNATHESWARA INSTTUTE OF AYURVEDA AND HOSPITAL, ANCHEPALYA, KUMBALGODU, BANGALURU, 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9481028050 |
| Fax |
|
| Email |
divyastuvert@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHWINI MJ |
| Designation |
M.S (Ayu), PROFESSOR AND HEAD |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN |
| Address |
DEPARTMENT OF SHALAKYA TANTRA,
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, B.M ROAD, THANNIRHALLA ,HASSAN
Hassan
KARNATAKA
573201
India |
| Phone |
9448222694 |
| Fax |
|
| Email |
drashwinidhanpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ASHWINI MJ |
| Designation |
M.S (Ayu), PROFESSOR AND HEAD |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN |
| Address |
DEPARTMENT OF SHALAKYA TANTRA,
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, B.M ROAD, THANNIRHALLA ,HASSAN
Hassan
KARNATAKA
573201
India |
| Phone |
9448222694 |
| Fax |
|
| Email |
drashwinidhanpal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR DIVYA STUVERT |
| Address |
ASSISTANT PROFFESOR,
DEPARTMENT OF SHALAKYA TANTRA, SRI DHARMASTHALA MANJUNATHESWARA INSTTUTE OF AYURVEDA AND HOSPITAL, ANCHEPALYA, KUMBALGODU, BANGALURU ,560074
|
| Type of Sponsor |
Other [self] |
|
|
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 ASHWINI MJ PhD GUIDE |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL |
DEPARTMENT OF SHALAKYA TANTRA, OPD AND IPD SECTION, B.M ROAD, THANNIRHALLA ,HASSAN -573201
Hassan
KARNATAKA |
9448222694
drashwinidhanpal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| COMMUNICATION OF DECISION OF INSTITUTIONAL ETHICS COMMITTEE, SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Jala Arka eye drops
|
Jala Arka (Distilled water) eye drop (Placebo) 3 drops 3 times daily for 60 days
|
| Intervention |
Study Group- Shwetha Palandu Arka eye drops
|
Shwetha Palandu Arka - White variety onion distilled eye drop 3 drops 3 times daily for 60 days
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Visual acuity of 6/60 or less
Informed Consent Form
|
|
| ExclusionCriteria |
| Details |
Patients with Senile Mature and Hyper mature Cataract
Pregnant and Lactating mothers
Congenital, developmental, traumatic, complicated or metabolic cataract
Any other ocular pathology that can cause diminution of vision was excluded from the study
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual acuity, Refraction, Direct opthalmoscopy, Auto refractometrey and slit lamp examination |
Periodic follow up of the patients on 15th day, 30th day, 45th day, 60th day, 75th day, 90th day will be done. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blurred vision, glare and floaters |
Periodic follow up of the patients on 15th day, 30th day, 45th day, 60th day, 75th day, 90th day will be done. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 3 |
|
Date of First Enrollment (India)
|
01/06/2020 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
A RANDAMIZED DOUBLE BLIND PLACEBO CONTROLLED CLINICAL STUDY ON ANTI- CATARACT EFFECT OF SHWETHA PALANDU EYE DROP IN THE MANAGEMENT OF KAPHAJA TIMIRA (IMMATURE CATARACT):A PILOT STUDY IN INTERNATIONAL AYURVEDIC MEDICAL JOURNAL Published in Volume IV, Issue I, Oct-Nov 2019, ISSN 2320-5091,Impact Factor: 5.344, Ref.No.P4.01.08 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cataract is an important cause of visual impairment and blindness, affecting 12 to 15 million persons worldwide. The incidence of cataract is distinctly more in developing tropical countries. In India, approximately 3.8 million persons become blind from cataract each year. Owing to the increased rate of incidence of cataract, non availability of effective medical measures and the possible complications and contraindications of surgery, Ayurveda offers an avenue of research for the need of drugs which can effectively manage Current study is open label two arm randomized double blind placebo controlled clinical study on Anti cataract effect of Shwetha Palandu eye drop in the management of Kaphaja Timira in immature cataract.200 Patients with the classical features of Kaphaja Timira (immature cataract) will be selected for the study. A combination of ‘before and after design’ is selected to compare the effect of trail drug and placebo drug before and after treatment in 2 groups. ‘Two eye study design’ to use both the eye for data collection. ‘Worst Eye Study Design’ is taken up for the eye with lowest visual acuity for analysis when both eyes are involved. For Study Group 100 patients with Shwetha Palandu Arka eye drop and for Control Group 100 patients with Jala Arka eye drop (Placebo) will be selected. Dosage will be 3 drops 3 times daily. Duration of treatment will be 60 days. Periodic follow up of the patients on 15th day, 30th day, 45th day, 60th day, 75th day, 90th day will be done. Subjective parameter are Blurred vision, glare and floaters. Objective parameter are examination of lens by Slit lamp,Visual Acuity by LogMAR chart, Contrast Sensitivity test by - PELLI ROBSON CHART, Refraction by Auto Refractometer readings with Manual correction, Type of Cataract by Direct Ophthalmoscope, Anterior Segment Photography for cataract with RETRO ILLUMINATION CAMERA and Assessing cataract opacity by LOCS III GRADING. The participants will be allowed to withdraw
from the trial if there is any major ailment necessitating the institution of
new modalities of treatment. Any adverse event, observed during the treatment
period or during follow up visits will be clearly documented using ADR form and appropriate and timely management will be done. |