| CTRI Number |
CTRI/2023/02/050137 [Registered on: 27/02/2023] Trial Registered Prospectively |
| Last Modified On: |
27/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Mustadi Yapana Basti Punarnavadi Ghanavati Veerataradi Ghanavati Trikantakadi Ghanavati in Chronic Kidney Disease |
|
Scientific Title of Study
|
Three Arm Randomized Comparative Clinical Study To Evaluate the Combined Effect of Mustadi Yapana Basti Followed by Punarnavadi Ghanavati Veerataradi Ghanavati And Trikantakadi Ghanavati in Chronic Kidney Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwini Sajjanavar |
| Designation |
Assistant Professor |
| Affiliation |
AYURVEDA MAHAVIDYALAYA HUBLI |
| Address |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIDYANAGAR BAGALKOT ROAD VIJAYAPUR
AYURVEDA MAHAVIDYALAYA & HOSPITAL HEGGERI EXTENSION OLD HUBLI 580024
Dharwad
KARNATAKA
586109
India |
| Phone |
7406737888 |
| Fax |
|
| Email |
dr.ashwini.sajjan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth A S |
| Designation |
Principal |
| Affiliation |
AYURVEDA MAHAVIDYALAYA HUBLI |
| Address |
AYURVEDA MAHAVIDYALAYA & HOSPITAL HEGGERI EXTENSION OLD HUBLI 580024
AYURVEDA MAHAVIDYALAYA & HOSPITAL HEGGERI EXTENSION OLD HUBLI 580024
Dharwad
KARNATAKA
580024
India |
| Phone |
9448135575 |
| Fax |
|
| Email |
drprashanthas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Sajjanavar |
| Designation |
Assistant Professor |
| Affiliation |
AYURVEDA MAHAVIDYALAYA HUBLI |
| Address |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA HOSPITAL & RESEARCH CENTER BAGALKOT ROAD VIJAYAPUR
AYURVEDA MAHAVIDYALAYA & HOSPITAL HEGGERI EXTENSION OLD HUBLI 580024
Dharwad
KARNATAKA
586109
India |
| Phone |
7406737888 |
| Fax |
|
| Email |
dr.ashwini.sajjan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda Mahavidyalaya Hubballi 580024 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Ashwini Sajjanavar |
| Address |
Assistant Professor
BLDEAS AVS AYURVEDA MAHAVIDYALAYA BAGALKOT ROAD VIJAYAPUR |
| 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 ASHWINI SAJJANAVAR |
AYURVEDA MAHAVIDYALAYA HUBLI |
AYURVEDA MAHAVIDYALAYA HEGGERI EXTENSION OLD HUBLI 580024
Dharwad
KARNATAKA |
7406737888
dr.ashwini.sajjan@gmail.com |
| DR ASHWINI SAJJANAVAR |
BLDEAs AVS Ayurveda Mahavidyalaya, Hospital and Research centre, Vijayapura-586109 |
BLDEAs AVS Ayurveda Mahavidyalaya, Hospital and Research centre, Vijayapura-586109
Bijapur
KARNATAKA |
7406737888
dr.ashwini.sajjan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N182||Chronic kidney disease, stage 2 (mild). Ayurveda Condition: MUTRAGHATAH, (2) ICD-10 Condition:N189||Chronic kidney disease, unspecified. Ayurveda Condition: CKD, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: CHARAKA SAMHITA SIDDHISTHANA , Procedure details: KALABASTI
MUSTADI YAPANA
16DAYS)
(1) Medicine Name: PUNARNAVADI GHANAVATI, Reference: SHARANGADHARA SAMHITA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: tds, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: CHARAKA SAMHITA SIDDHISTHANA, Procedure details: KALABASTI
16DAYS
MUSTADI YAPANA BASTI)
(1) Medicine Name: VEERATARADI GHANAVATI, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: tds, Duration: 30 Days | | 3 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: CHARAKASAMHITA SIDDHISTHANA, Procedure details: MUSTADI YAPANA BASTI
KALABASTI
16DAYS)
(1) Medicine Name: TRIKANTAKADI GHANAVATI, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: tds, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Chronic Kidney Disease Patients.
➢ Subjects who are fit for Bastikarma.
➢ Subjects having classical common signs and symptoms Gaurava,Anavasthita
utseda,Siratanutwa,Salomaharsha,Angavivarnata,Sashoolamutrata,Raktamootrata.
➢ Subjects with classical symptoms of Chronic Kidney Disease having clinical features like oedema,pruritis,
generalized weakness, nausea.
➢ Stages 1, 2 and 3 Glomerular Filtration Rate (30-ml/min per 1.73m2
)
➢ Microalbuminuria( ACR- 30 to 300mg/g ≥3 months)
➢ Mild hypertension(<130/80MMHG)
➢ Patients aged between 20-70years.
➢ Patients of either sex will be taken for study. |
|
| ExclusionCriteria |
| Details |
Patients of Congenital Renal Diseases like Autosomal dominant and Recessive Polycystic Kidney disease,
Congenital Nephrotic syndrome (Finnish type), Alport’s syndrome, Fabry‘s disease and
Juvenile Nephronopthisis.
➢ Subjects who are on dialysis.
➢ Uncontrolled Dm.(HBA1C ≥7)
➢ Pregnant women. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ALPAMUTRATA PADASHOTHA |
30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SERUM CREATININE GFR LEVELS |
30DAYS |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2023 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study entitled THREE ARM RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE COMBINED EFFECT OF MUSTADI YAPANA BASTI FOLLOWED BY PUNARNAVADI GHANAVATI VEERATARADI GHANAVTI AND TRIKANTAKADI GHANAVATI is to be conducted at Ayurveda Mahavidyalaya Hubli and BLDEA’S AVS Ayurveda Mahavidyalaya Vijayapur. This study is mainly focussed on the management of Chronic Kidney Disease and for the betterment of the patients through Ayurvedic intervention. |