| CTRI Number |
CTRI/2019/03/018184 [Registered on: 20/03/2019] Trial Registered Prospectively |
| Last Modified On: |
12/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of Vasaghrita drops and calcium chloride eye drop in senile cataract |
|
Scientific Title of Study
|
Randomized controlled clinical trial to study the effect of Vasaghrita Aschyotana and Calcium Chloride eyedrop in Kaphaj Timir |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Rajnigandha Chandraprakash Manwar |
| Designation |
M.S scholar Shalakyatantra (Ayurved Dhanvantari) |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College |
| Address |
OPD NO 9, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune
Maharashtra-411028
Malwadi Road, Hadapsar, Pune
Maharashtra-411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9404237153 |
| Fax |
|
| Email |
pinkymanwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravin M Bhat |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College |
| Address |
OPD NO 9, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune
Maharashtra-411028
Malwadi Road, Hadapsar, Pune
Maharashtra-411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9860233173 |
| Fax |
|
| Email |
vdpravin82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravin M Bhat |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College |
| Address |
OPD NO 9, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune
Maharashtra-411028
Malwadi Road, Hadapsar, Pune
Maharashtra-411028
MAHARASHTRA
411028
India |
| Phone |
9860233173 |
| Fax |
|
| Email |
vdpravin82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune-411028 |
| 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 |
| Vd Rajnigandha Chandraprakash Manwar |
Sane Guruji Arogya Kendra,Malwadi road, Hadapsar, Pune-411028 |
Opd no 9, Department of Shalakyatantra
Pune
MAHARASHTRA |
9404237153
pinkymanwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H25||Age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium Chloride eye drop |
one drop two times a day for 45 days |
| Intervention |
Vasaghrita Aschyotana |
Vasaghrita Aschyotan in the form of drops 1drop two times a day for 45 days |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients suffering from symptoms of Kaphaja Timira.
2) Patients of age group 50 to 70 yrs.
3) Patients of either gender will be included in the study.
4) Visual acuity of 6/12 or less.
|
|
| ExclusionCriteria |
| Details |
1)Mature and Hypermature cataract.
2) Congenital, traumatic, complicated & metabolic cataract.
3) Any ocular pathology that can cause diminution of vision.
4) Visual acuity of less than 6/60.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A comparative clinical study to evaluate efficasy of Vasaghrita Aschyotana and Calcium Chloride eye drop in Kaphaj Timir |
The drug will be given 45 days. The patients will be assessed before and after treatment. Total duratin of the study will 18 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Delay in maturity of senile immature cataract. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 open labelled randomized controlled clinical trial to evaluate the effect of Vasaghrit Aschyotan applied twice daily for 45 days in comparison with calcium chloride eye drops in eye/ eyes of patients affected with Kaphaj Timir. The Primary outcome will be effect of Vasaghrita Aschyotan and the secondary outcome will be the delay in maturity of senile immature cataract. |