| CTRI Number |
CTRI/2024/12/078689 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to observe the effect of two drugs, Mahavasakadi Kwatha and Chandrakala Rasa along with Darvyadi Anjana in patients with Non Proliferative Diabetic Retinopathy |
|
Scientific Title of Study
|
A CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF
CHANDRAKALA RASA IN THE MANAGEMENT OF NON-PROLIFERATIVE DIABETIC RETINOPATHY
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushobhitha M |
| Designation |
Assistant professor |
| Affiliation |
SDM Institute of Ayurveda and Hospital Bengaluru |
| Address |
Department of Shalakya Tantra
SDM Institute of Ayurveda and Hospital
Anchepalya Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
770767967 |
| Fax |
|
| Email |
msushobhitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Munawar Pasha |
| Designation |
Professor and Head of the department |
| Affiliation |
Government Ayurveda medical college, Bengaluru |
| Address |
Room no- 11, Department of Shalakya tantra, Government Ayurveda medical college, Dhanvanthari road, Bengaluru-
Bangalore
KARNATAKA
560009
India |
| Phone |
9886593932 |
| Fax |
|
| Email |
smpasha78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Syed Munawar Pasha |
| Designation |
Professor and Head of the department |
| Affiliation |
Government Ayurveda medical college, Bengaluru |
| Address |
Room no- 11, Department of Shalakya tantra, Government Ayurveda medical college, Dhanvanthari road, Bengaluru-
Bangalore
KARNATAKA
560009
India |
| Phone |
9886593932 |
| Fax |
|
| Email |
smpasha78@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sushobhitha M |
| Address |
DR SUSHOBHITHA M
Assistant professor
Department of Shalakya Tantra
SDM Institute of Ayurveda and
Hospital Anchepalya Kumbalagodu
Bengaluru 560074
Karnataka, India
|
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Syed Munawar Pasha |
Govrnment Ayurveda Medical College |
OPD#11,
Govrnment Ayurveda Medical College
Dhanwantari Road
Bengaluru 560009
Bangalore
KARNATAKA |
9886593932
smpasha78@gmail.com |
| Dr Sushobhitha M |
SDM Institute of Ayurveda and Hospital |
OPD#16,
SDM Institute of Ayurveda and Hospital
Anchepalya Kumbalgodu
Bengaluru 560074
Bangalore
KARNATAKA |
7760767967
msushobhitha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Government Ayurveda Medical College Bengaluru |
Approved |
| Institutional ethics committee SDM Institute of Ayurveda and Hospital Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H350||Background retinopathy and retinalvascular changes. Ayurveda Condition: PRAMEHA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahavasakadi Kwatha, Reference: Yogaratnakara Netra rogadhikara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 48 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - | | 2 | Intervention Arm | Procedure | - | anjana karma | (Procedure Reference: Sushrutha Uttara tantra Chapter 18, Procedure details: Darvyadi Anjana-2 Vidangamatra (40 mg), once in the morning for 48 days.
)
(1) Medicine Name: Darvyadi anjana, Reference: Yogaratnakara Netrarogadhikara, Route: Ocular, Dosage Form: Kalka/ Paste, Dose: 40(mg), Frequency: od, Duration: 48 Days | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chandrakala rasa, Reference: Bhaishajya ratnavali , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 48 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - | | 4 | Comparator Arm | Procedure | - | anjana | (Procedure Reference: Sushrutha Uttaratantra Chapter 18, Procedure details: Darvyadi Anjana-2 Vidangamatra (40 mg), once in the morning for 48 days.
)
(1) Medicine Name: Darvyadi anjana, Reference: Yogaratnakara Netrarogadhikara, Route: Ocular, Dosage Form: Kalka/ Paste, Dose: 40(mg), Frequency: od, Duration: 48 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with minimal visual acuity of 6/36
Patients having minimum history of DM for 10 years
Patients with good glycemic control HbA1C less than 7
|
|
| ExclusionCriteria |
| Details |
Patients having proliferative diabetic retinopathy changes
Patients with history of visual impairments like glaucoma and matured lenticular opacity changes
Patients with history of Pathological myopia and other degenerative conditions
Patients with other systemic disorders which may interfere with the course of study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective and objective parameters |
7weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sustained effect of treatment on subjective and objective parameters
Effect on blood sugar level |
3 year |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
03/01/2025 |
| 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="3"
Months="2"
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
|
Patients with diabetes are more likely to
develop eye problems such as cataract and glaucoma, but the disease’s effect on
the retina is the main threat to vision.
Diabetic retinopathy refers to retinal
changes seen in the patients of diabetes mellitus.Diabetic
retinopathy is an ocular micro angiopathy characterized by capillary leakage,
hemorrhages, and intra retinal micro vascular abnormalities. It is estimated that all people of
type 1 diabetes mellitus (IDDM), 75% of type 2 diabetes mellitus (NIDDM) will
develop diabetic retinopathy after 15 years of duration.18% will develop
retinopathy in less than 15 years of duration In
Ayurveda, Prameha is considered as Mahagada
and if not properly managed leads to upadravas It
has been mentioned ‘Hrunnetrajihwashravanopadeha’ in the context of Prameha
poorvaroopa which
gives clue regarding involvement of eye in pramehasamprapthi, The
doshas and dhatus which causes the main disease are also responsible for the
manifestation of the upadravas
In
prameha
major samprapthi
ghataka
is kleda
which contribute much to upadrava
rogas.
In
Ayurveda
many works have been undertaken with promising results in diabetic
retinopathy.( Anjana, shirolepa,
takradhara).
Aiming
at restoration of structural and functional integrity of the disease, a
comparative clinical study using, Darvyadi
Anjana, Mahavasadi
kwatha
and Chandrakala rasa orally taken up in the present work, which is said to have
properties of controlling raktasrava,
shopha
pacifying kaphapittta
and having chakshushya. |