| CTRI Number |
CTRI/2025/07/090815 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EFFECT OF APPLYING GUDUCHI RASAKRIYA ANJANAM IN IMMATURE SENILE CATARACT |
|
Scientific Title of Study
|
EFFECT OF GUDUCHI RASAKRIYA ANJANAM IN IMMATURE SENILE CATARACT A PRE POST INTERVENTIONAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sneha Nair |
| Designation |
P G SCHOLAR |
| Affiliation |
Government Ayurveda College Kannur |
| Address |
Dr Sneha Nair
First Year PG Scholar,
Department Of Shalakyatantra
Government Ayurveda college Pariyaram PO Kannur
670503
Kannur
KERALA
670503
India |
| Phone |
7012049125 |
| Fax |
|
| Email |
snehanair753@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V K V Balakrishnan |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College Kannur |
| Address |
Dr V K V Balakrishnan
Professor and HOD
Department of Shalakyatantra
Government Ayurveda college Pariyaram PO Kannur 670503
Kannur
KERALA
670503
India |
| Phone |
9447037892 |
| Fax |
|
| Email |
baluvkv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V K V Balakrishnan |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College Kannur |
| Address |
Dr V K V Balakrishnan
Professor and HOD
Department of Shalakyatantra
Government Ayurveda college Pariyaram PO Kannur 670503
Kannur
KERALA
670503
India |
| Phone |
9447037892 |
| Fax |
|
| Email |
baluvkv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Kannur |
|
|
Primary Sponsor
|
| Name |
Sneha Nair |
| Address |
Dr Sneha Nair
Government Ayurveda college Pariyaram PO Kannur
670503 |
| Type of Sponsor |
Other [Individual Sponsor( 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 Sneha Nair |
Government Ayurveda College |
Government Ayurveda College
Pariyaram PO
Kannur
670503
Kannur
KERALA |
07012049125
snehanair753@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Govt. Ayurveda College, Kannur |
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: KACAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchi Rsakriya Anjanam, Reference: Sharangadhara Samhitha, Route: Ocular, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -NIL |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed as IMSC based on symptoms such as floaters and glare, presence of iris shadow and diagnosed as immature senile cataract as per LOCSIII criteria .
Subjects willing to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Subjects who are contra indicated for anjana karma.
Subjects with diabetes mellitus.
Subjects with inflammatory and infective diseases of eye ball and its appendages.
Subjects who are under steroid medication for past 1 month.
Subjects with any other ocular pathology that causes diminished vision.
Subjects with visual acuity greater than 0.3 on log MAR scale.
Subjects with a score less than 1.0 log units in Pelli Robson contrast sensitivity scale.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual acuity assessed by log MAR visual acuity chart
Contrast sensitivity assessed by Pelli Robson contrast sensitivity chart
Change in grade of cataract assessed by LOCSIII.
|
Assessment will be done on 0 th day, 8 th day, 22nd day, 30th day, 45th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/11/2025 |
| 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 Yet Recruiting |
| 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
|
The term cataract refers to
development of any opacity in the lens or its capsule. Age related cataract or
senile cataract is the most common type of acquired cataract. The symptoms
include glare, coloured halos, black spots in front of eyes, distorted images
and gradually progressive loss of vision. In modern medicine treatment of cataract essentially consists of
its surgical removal.[1]These symptoms resemble Kaphaja
kacha in Ayurveda.Guduchi Rasakriya Anjanam is indicated in timira
and kacha chikitsa. Triphala is advised to be taken with ghritham
in timira chikitsa.This pre and post-interventional study aims to assess the combined effect of Guduchi rasakriya anjanam twice daily and internal use of 5gm Triphala choornam with ghritham for 21 days in 33 subjects aged 50- 75 years with immature senile cataract attending the Out Patient Department of Shalakyatantra, Government Ayurveda College Hospital, Kannur in reducing symptoms like glare and floaters and improving visual acuity, contrast sensitivity and LOCSIII grading of cataract. Assessment will be done before and after Poorvakarma, on the 1st day of intervention, on 22nd day after the intervention and on the Follow up after a gap of 15 days. Results will be statistically analysed.
|