| CTRI Number |
CTRI/2024/02/062852 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Dwitiya patalgata timira wsr immature cataract |
|
Scientific Title of Study
|
Clinical study on the effect of Chitrakadi kashaya internally and Nilotpaladi anjana in dwitiya patalgata timira wsr to immature cataract |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shila Sapkota |
| Designation |
MS scholar |
| Affiliation |
Dr BRKR Govt Ayurvedic Medical College, |
| Address |
Room no 11, Shalakya Department, Dr BRKR Govt Ayurvedic medical college,Erragadda,Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
8520977417 |
| Fax |
|
| Email |
shilasapkota24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ch Ramadevi |
| Designation |
PG Professor and Head of Department |
| Affiliation |
Dr B.R.K.R Governement ayurvedic college . |
| Address |
Shalakya department , Dr B.R.K.R Government Ayurveda college and hospital
Erragadda, Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9849164668 |
| Fax |
|
| Email |
rama.sreerangam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ChRamadevi |
| Designation |
PG Professor and Head of Department |
| Affiliation |
Dr B.R.K.R Governement ayurvedic college . |
| Address |
Shalakya department , Dr B.R.K.R Government Ayurveda college and hospital
Erragadda, Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9849164668 |
| Fax |
|
| Email |
rama.sreerangam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. B.R.K.R Govt.Ayurevdic medical college |
|
|
Primary Sponsor
|
| Name |
Dr BRKR Govt Ayurvedic college |
| Address |
Dr BRKR Govt Ayurvedic medical college,SR nagar, Hyderabad |
| Type of Sponsor |
Government 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 Shila Sapkota |
Dr. B.R.K.R Government Ayurvedic Medical college |
OPD no:11, Dr. B.R.K.R Government Ayurvedic medical college.
Hyderabad
TELANGANA |
8520977417
shilasapkota24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committe of Dr BRKR Goverment Ayurvedic College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H259||Unspecified age-related cataract. Ayurveda Condition: Immature cataract, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | - | | |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All age related immature cataract 30 years or above. Patient having symptoms of Dwitiya Patalagata Timira like Dristi bhramsa(Blurring of vision),Vihwala darsan(Confusing and hazy vision),Dristi gochara vibhrama(Distortion of vision),Varsabhramam tamamshi(Misty vision),
Dwidha darshan (Diplopia)
|
|
| ExclusionCriteria |
| Details |
Patients having immature cataract below 30 years.
Mature cataract/hypermature cataract
Complicated cataract
Secondary/associated cataract(cataract secondary to other systemic diseases like uncontrolled Diabetes )
Congenital cataract
Traumatic cataract
Uncontrolled hypertension
Uncontrolled diabetes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in visual acuity |
42 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in quality of life |
42days |
|
|
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)
|
22/02/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized clinical trial on the effect of Chitrakadi kashaya internally and Nilotpaladi anjana in dwitiya patalagata timira wsr to immature cataract in patients who will be clinically diagnosed and confirmed cases of immature cataract enlisted in inclusion criteria will be in single group of total 30 patients. They will be given Chitrakadi kashaya orally 20 ml at bed time with anupana ghrita for 42 days. Then they will be given Nilotpaladi varti anjana for 42 days. follow up to 42 days in interval of 21 days.
|