| CTRI Number |
CTRI/2025/04/085734 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to observe the effect of Navak Guggul Yog in the management of non-proliferative Diabetic Retinopathy .
|
|
Scientific Title of Study
|
An open labelled, Randomised clinical control study to evaluate the effect of Navak Guggul Yog in the management of non-proliferative Diabetic Retinopathy (NPDR)- Preclinical 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 |
Ambore Pallavi Prashant |
| Designation |
M.S ( First year ), Shalakyatantra |
| Affiliation |
R.A Podar Medical ( Ayu) college, Worli Mumbai 400018 |
| Address |
OPD no 20 ,shalakyatantra department ,R.A Podar Medical (Ayu) college & M.A Podar Medical Hospital, worli Mumbai 400018, Maharashtra
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9579400094 |
| Fax |
|
| Email |
amborepallu123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrut Salunke |
| Designation |
HOD & Professor |
| Affiliation |
R.A Podar Medical Ayu College, Worli Mumbai 400018 |
| Address |
HOD of Shalakyatantra department,R.A Podar Medical Ayu College,Worli Mumbai 400018 , Maharashtra
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9819139017 |
| Fax |
|
| Email |
dramrut16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ambore Pallavi Prashant |
| Designation |
M.S First year Shalakyatantra |
| Affiliation |
R.A Podar Medical Ayu College Worli Mumbai 400018 |
| Address |
OPD no 20 ,Shalakyatantra Department ,R.A Podar Medical Ayu College & M.A podar Hospital Worli Mumbai 400018 , Maharashtra
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9579400094 |
| Fax |
|
| Email |
amborepallu123@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no 20 ,Shalakyatantra OPD ,Shalayatantra department , M .A Podar Ayurvedic hospital ,worli , mumbai 400018 |
|
|
Primary Sponsor
|
| Name |
Ambore Pallavi Prashant |
| Address |
Department of shalakyatantra ,R.A Podar Medical Ayu college Worli Mumbai Maharashtra 400018 |
| 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 Pallavi Prashant Ambore |
M.A Podar Ayurvedic Hospital Worli ,Mumbai 400018 |
OPD no 20 , shalakya tantra OPD ,shalakyatantra department of M.A podar Ayurvedic hospital ,worli,Mumbai 400018
Mumbai
MAHARASHTRA |
9579400094
amborepallu123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: PRAMEHA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | | | 2 | Comparator Arm (Non Ayurveda) | | - | Antioxidant tablet | Vit c 500 mg , vit E 400IU , Lutein 10 mg , Zeaxanthin 2 mg , Zinc 80 mg , Copper 2 mg
1 tablet per day , before breakfast for 90 days | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Navak Guggul Yog , Reference: Yogratnakar ,Medorog Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: koshna jal ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Sign and symptoms of nonproliferative diabetic
Retinopathy.
Age 40 - 60 years .
Patient having type 2 DM with hba1c less than 8 .
Hypertensive patients having controlled bp less than 140/90mmhg. |
|
| ExclusionCriteria |
| Details |
Proliferative Diabetic Retinopathy
Uncontrolled Bp & bsl
Infective & inflammatory conditions of eye
Hiv , cox , Hbs Ag positive
Not willing |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of navak guggul yog in the management of non proliferative Diabetic Retinopathy |
90 days...follow up on every 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To observe the addon effect of Navak guggul yog in micro aneurysm, retinal haemorrhage and hard exudates in NPDR.
2.to study whether navak guggul yog prevent the progression of non proliferative Diabetic Retinopathy to proliferative Diabetic Retinopathy .
3.to study the effect of Navak guggul yog on visual acuity in non proliferative diabetic Retinopathy
|
90 days
Monthly follow up |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
10/05/2025 |
| 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 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
|
Diabetic mellitus is a major non epidemic metabolic disorder affecting over million people worldwide .the disorder is rapidly increasing out in developing and developed countries , especially type 2 Diabetes Mellitus which is associated with the modern lifestyle habits such as reduced physical activity ,diet ,obesity and genetic factors . Major complications of DM are heart disease , stroke ,kidney failure,foot ulcers,microvascular ischemic diseases , peripheral artery disease,microvascular neuropathy,nephropathy and retinopathy . Diabetic Retinopathy is a chronic progressive potentially sight threatening disease. Existing conventional therapy of treatment of diabetic mellitus is not preventing the development of diabetic Retinopathy . According to WHO expert committee diabetes mellitus is major cause of avoidable blindness , good glycemic control arrest the development and progression of diabetic Retinopathy and decrease the visual loss . Who recommended that traditional system of medicine should be encouraged for prevention and treatment of diabetes mellitus complications especially when conventional pharmacotherapy is not full effective . Hence Navak guggul yog is well known polyherbal formulation for Diabetic Retinopathy and other DM complications.it acts as kaphagna and medoghna and thus can have an additive protective and preventive role in diabetes mellitus . The aim of present study was to confirm and illustrate the mechanism of protective action of Navak guggul yog in prevention of Diabetic Retinopathy and its complications .
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