| CTRI Number |
CTRI/2022/03/041425 [Registered on: 28/03/2022] Trial Registered Prospectively |
| Last Modified On: |
23/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Trikantakadi Guggulu And Ervarubijadi Kwath In The management of Chronic Kidney Disease |
|
Scientific Title of Study
|
A CLINICAL STUDY OF TRIKANTAKADI GUGGULU AND ERVARUBIJADI KWATH ANUPAN IN THE MANAGEMENT OF MUTRAGHAT W.S.R. 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 Awadhesh Sahu |
| Designation |
Pg Scholar Kayachikitsa Department |
| Affiliation |
Shri narayan prasad awasthi, Govt Ayurveda College Raipur C.G. |
| Address |
OPD no 2, Department of Kayachikitsa, Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
7804989037 |
| Fax |
|
| Email |
drawadheshkumarsahu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S D Khichariya |
| Designation |
Lecturer Kayachikitsa |
| Affiliation |
Shri narayan prasad awasthi, Govt Ayurveda College Raipur C.G. |
| Address |
Department of Kayachikitsa, Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9826196400 |
| Fax |
|
| Email |
drkhichariya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S D Khichariya |
| Designation |
Lecturer Kayachikitsa |
| Affiliation |
Shri narayan prasad awasthi, Govt Ayurveda College Raipur C.G. |
| Address |
Department of Kayachikitsa, Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9826196400 |
| Fax |
|
| Email |
drkhichariya@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF KAYACHIKITSA SHRI NARAYAN PRASAD AWASTHI GOVT. AYURVEDA COLLEGE RAIPUR C.G. |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa Shri Narayan Prasad Awasthi Ayurveda College Raipur Chhattisgarh |
| Address |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 492010 |
| Type of Sponsor |
Other [Government Ayurveda College Raipur ] |
|
|
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 Awadhesh Sahu |
Shri Khudadad Doongaji Govt. Ayurveda Hospital Raipur C.G. |
Department of Kayachikitsa, OPD no.2 and IPD, Govt. Ayurveda hospital Raipur C.G.
Raipur
CHHATTISGARH |
7804989037
drawadheshkumarsahu@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurveda College Raipur C.G. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N189||Chronic kidney disease, unspecified. Ayurveda Condition: MUTRAGHATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trikantakadi Guggulu, Reference: Yogratnakar Mutrakrichha Chikitsa 4 Page no. 58, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Ervarubijadi Kwath with added Punarnava and Corn Silk Extract), Additional Information: Ervarubijadi Kwath, Reference: -Ashtang Hridayam Chikitsa Sthan 11/8 Page no. 708 |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Known CKD patients with Blood serum creatinine level less than 5 mg/dl, Blood urea level less than 100 mg/dl, Stable patients of DM type 2 or Hypertension |
|
| ExclusionCriteria |
| Details |
Terminal stage of CKD patients, Ruled out renal stone patients, Patients need for hemodialysis, Blood serum creatinine level more than or equal to 5 mg/dl, Blood urea level more than or equal to 100 mg/dl, GFR less than 30ml/min, Unstable patient of DM type 2 or Hypertension, Cancer, AIDS, Corona |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the symptom of CKD |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improve the Quality of Life |
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mutraghat (chronic kidney disease) is a progressive form of Renal disorder and may appear at the stage of irreversible damage. CKD is identified by Blood test for Creatinine ,
which is a breakdown product of muscle metabolism. Higher level of Creatinine
indicates a lower GFR and as a result
decreased capability of the Kidneys to excrete products. The modern method of treatment is not satisfactory for CKD patients and causes many adverse reactions. A total number of 30 patients will be selected for this study and will be advised Trikantakadi gugglu with anupana of Eravarubijadi kwath added with punarnava and cornsilk extract for 60 days. During treatment follow up will be done weekly, and post treatment follow up will be done every 15 days. Assessment will be done on the basis of subjective and objective criteria adopted for this study. |