| CTRI Number |
CTRI/2025/05/086271 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
04/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study of mutraja vikrita kleda and efficacy of Katak beeja churna in diseases like diabetes melllitus and chronic renal failure with special reference to routine urine examination. |
|
Scientific Title of Study
|
A clinical study of mutraja vikrita kleda and efficacy of Kataka beeja churna with special reference to routine urine examination. |
| 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 Dhanwantari Behera |
| Designation |
PG Scholar |
| Affiliation |
Govt Ayurvedic College And Hospital Guwahati Assam |
| Address |
Dept of Roga Nidan
Govt Ayurvedic College And Hospital Ghy14 Assam
Kamrup
ASSAM
781014
India |
| Phone |
8144719750 |
| Fax |
|
| Email |
kdhani1207@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup Baishya |
| Designation |
Professor Head of Department and Guide |
| Affiliation |
Govt Ayurvedic College And Hospital Guwahati Assam |
| Address |
Dept of Roga Nidan
Govt Ayurvedic College And Hospital Ghy14 Assam
Kamrup
ASSAM
781014
India |
| Phone |
8638211711 |
| Fax |
|
| Email |
baishya.anup.815@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anup Baishya |
| Designation |
Professor Head of Department and Guide |
| Affiliation |
Govt Ayurvedic College And Hospital Guwahati Assam |
| Address |
Dept of Roga Nidan
Govt Ayurvedic College And Hospital Ghy14 Assam
Kamrup
ASSAM
781014
India |
| Phone |
8638211711 |
| Fax |
|
| Email |
baishya.anup.815@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVT AYURVEDIC COLLEGE AND HOSPITAL GHY14 |
|
|
Primary Sponsor
|
| Name |
Dr Dhanwantari Behera |
| Address |
Dept of Roga Nidan
Govt Ayurvedic College And Hospital Jalukbari GHY14 Assam |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CCRAS |
Central Council for Research in Ayurvedic Sciences D Block Janakpuri Institutional Area Janakpuri New Delhi 110058 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhanwantari Behera |
Govt Ayurvedic College And Hospital Jalukbari Assam |
OPD and IPD of Dept.of Roganidan,Govt Ayurvedic College And Hospital Ghy14 Assam
Kamrup
ASSAM |
08144719750
kdhani1207@gmail.com |
| Dr Dhanwantari Behera |
INSTITUTE OF ADVANCED STUDY IN SCIENCE AND TECHNOLOGY |
VIGYAN PATH GARCHUK PASCHIM BORAGAON
Kamrup
ASSAM |
08144719750
kdhani1207@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Govt Ayurvedic College and Hospital,Jalukbari, Guwahati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E112||Type 2 diabetes mellitus with kidney complications. Ayurveda Condition: PRAMEHA-UPADRAVAH, (2) ICD-10 Condition:N189||Chronic kidney disease, unspecified. Ayurveda Condition: MUTRAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Katak Beej, Reference: Yoga Ratnakar,Prameha Rogadhikar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Takra/Madhu), Additional Information: -Churna of Katak beej will be grinded with Takra then taken with Madhu |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients within the age of 18 to 70 years of both sexes having symptoms of Mutraja Vikrita Kleda will be taken.
2. All the selected patients who well give their consent for clinical study will be included.
3. Patient with diagnosed case of chronic renal failure (CRF) with proteinuria
4. Patient with clinical symptoms of diabetic nephropathy.
|
|
| ExclusionCriteria |
| Details |
1. Patients below 18 years and above 70 years, pregnant women and lactating mother.
2. Complicated chronic renal failure patients.
3. Patient with Sr. Creatinine more than 6mg/dl
4. Patient with the other systemic complication where needs other intervention.
5. Patient with systemic diseases and immunocompromised states like HIV, TB, Hepatitis B, Hepatitis C
6. Patients with malignancy
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Kataka beeja churna in mutraja vikrita kleda includes diseases like diabetes mellitus with nephropathy and chronic renal failure without diabetes mellitus. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| An invitro study will be conducted to see the nephroprotective effect of Katak beej. |
08 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/05/2025 |
| 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="1"
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
|
This is a clinical study of Kataka beeja churna in the management of mutraja vikrita kleda where 2 groups of diseases will be taken namely chronic renal failure with diabetic nephropathy and chronic renal failure without diabetes mellitus.This study has also includes the objective to find the relation between mutraja vikrita kleda with the abnormalities of urine.Also an in vitro study is done to see the nephroprotective effect of Katak beej.This study is done as a mandatory post graduation thesis work.Total no of patients will be 60 to be studied for 45 days. |