| CTRI Number |
CTRI/2025/07/092024 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing the effect of ayurvedic kashaya as oral medicine and enema therapy in patients with kidney disease related to with diabetes. |
|
Scientific Title of Study
|
Effect of Gokshuradi kashaya pana and Gokshuradi ruksha vasti in Diabetic Nephropathy |
| 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 Haripriya Vijayan |
| Designation |
PG Scholar |
| Affiliation |
Govt Ayurveda College |
| Address |
Dept of Kayachikitsa Govt Ayurveda College Tripunithura Ernakulam Kerala India
Ernakulam
KERALA
682301
India |
| Phone |
7560857152 |
| Fax |
|
| Email |
haripriyavijayan1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil John Thykkattil MD Ayu |
| Designation |
Associate Professor |
| Affiliation |
Govt Ayurveda College Tripunithura Ernakulam |
| Address |
Dept of Kayachikitsa Govt Ayurveda College Tripunithura Ernakulam Kerala India
Ernakulam
KERALA
682301
India |
| Phone |
9447500822 |
| Fax |
|
| Email |
drsuniljohn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil John Thykkattil MD Ayu |
| Designation |
Associate Professor |
| Affiliation |
Govt Ayurveda College Tripunithura Ernakulam |
| Address |
Dept of Kayachikitsa Govt Ayurveda College Tripunithura Ernakulam Kerala India
Ernakulam
KERALA
682301
India |
| Phone |
9447500822 |
| Fax |
|
| Email |
drsuniljohn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurveda College and Hospital Tripunithura Ernakulam Kerala India 682301 |
|
|
Primary Sponsor
|
| Name |
Dr Haripriya Vijayan |
| Address |
Department of Kayachikitsa Govt Ayurveda College Tripunithura Ernakulam Kerala India Pincode 682301
India Pincode -682301 |
| Type of Sponsor |
Other [PG Scholar Govt Ayurveda College Tripunithura ] |
|
|
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 Haripriya Vijayan |
Govt Ayurveda College and Hospital Tripunithura Ernakulam |
Dept of Kayachikitsa Govt Ayurveda College Tripunithura Ernakulam Kerala 682301 India
Dept of Kayachikitsa Govt Ayurveda College Tripunithura Ernakulam Kerala
Ernakulam
KERALA |
07560857152
haripriyavijayan1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH Govt Ayurveda College Tripunithura Ernakulam Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N183||Chronic kidney disease, stage 3 (moderate). Ayurveda Condition: PRAMEHA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi kashayam , Reference: Sahasrayoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Along with Kashaya Ruksha vasti also done with Gokshuradi kashaya and sudarsana churna | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka Samhitha , Procedure details: First Sudarshana choorna is added into the vessel followed by the addition of Gokshuradi kashaya
and mixed to get a homogenous mixture, then filtered and given through anal route in lukewarm
temperature.
)
(1) Medicine Name: Gokshuradi kashaya, Reference: Sahasrayoga , Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 300(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed subjects of type 2 Diabetes Mellitus with Diabetic nephropathy
With age group between 35-70 yrs
With microalbumin ranges between 20 -200 microgram/min
S.Creatinine level within 5
Who are fit for Vasthikarma
Who are willing to participate and able to give consent |
|
| ExclusionCriteria |
| Details |
HbA1C greater than 9
Diabetic Nephropathy Stage 4 and 5
Pregnancy and lactation
Known case of uncontrolled other systemic illness
With persistent UTI
Taking ACE inhibitors and ARBs
Subjects with other severe debilitating diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Albumin Creatinine ratio |
0th and 31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in eGFR |
0th and 30th day |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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)
|
18/08/2025 |
| 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
|
This is an interventional study in a single group of participants where Gokshuradi kashaya is given internally for a period of 30 days and Gokshuradi ruksha vasti for 7 days in 1 2 and 3 stages of Diabetic Nephropathy. Ayurvedic interventions targeting the reversal of microalbuminuria and prevention of progression to overt Nephropathy and which causing reversal of the structural damage of nephrons is needed in this condition. Gokshuradi kashaya mentioned in Sahasrayoga sopha chikitsa is selected as the drug of choice for the study. Effect is assessed by Albumin creatinine ratio and eGFR. Assessment will be done on 0th and 31st day. |