| CTRI Number |
CTRI/2022/07/043780 [Registered on: 06/07/2022] Trial Registered Prospectively |
| Last Modified On: |
06/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
study to compaire the role of Ayurvedic and modern medicine in CKD. |
|
Scientific Title of Study
|
Comparative efficacy of Bruhatyadi Kwath as compare to furosemide for improving e-GFR and Albuminuria 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 |
Namrata A Shankarpure |
| Designation |
Assistant Professor |
| Affiliation |
MGAC AND RC |
| Address |
Kayachikita Department.
2nd floor,
Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Wardha
Maharashtra
Kayachikita Department.
2nd floor,
Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Wardha
Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
8850033874 |
| Fax |
|
| Email |
namrataashankarpure@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sadhana Misar |
| Designation |
Professor |
| Affiliation |
MGAC AND RC |
| Address |
Kayachikita Department.
2nd floor OPD NO.1
Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Wardha
Maharashtra
Kayachikita Department.
2nd floor OPD NO.1.
Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Wardha
Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9763732083 |
| Fax |
|
| Email |
sadhanamisar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadhana Misar |
| Designation |
Professor |
| Affiliation |
MGAC AND RC |
| Address |
Kayachikita Department
2nd floor OPD no.1
Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Wardha
Maharashtra
Kayachikita Department
2nd floor opd no.1
Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Wardha
Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9763732083 |
| Fax |
|
| Email |
sadhanamisar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital Savangi Wardha.pin coad:442001 Maharashra |
| Mahatma Gandhi Ayurved College Hospital And reseach Centre Salod(Hirapur)Wardha(DMIMS.DU).pin coad:442001 Maharashra |
|
|
Primary Sponsor
|
| Name |
MGACRC |
| Address |
Mahatma gandi ayurved college,hospital & research centre salod(H),Wardha maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| JNMC SAWANG WARDHA |
DATTA MEGHE INSTITUTE OF MEDICAL SCIENCE,SAWANGI WARDHA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Namrata Shankarpure |
Mahatma Gandhi Ayurved Collage Hospital And Research Centre |
Mahatma Gandhi Ayurved Collage Hospital And Research Centre Hirapur (DMIMS.DU) 2nd floor OPD no.1 Kayachikitsa Department
Sawangi meghe Wardha 442001, Maharashtra.
Wardha
MAHARASHTRA |
8850033874
namrataashankarpure@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee DMIMS MGAC Salod Wardha |
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), |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.age 20years to 70 years.
2. diagnosed patient of CKD (BEST on eGFR,and Albuminuria clinically stable patient of stage 1to3 will be included
stage 1- GFR>90.
stage2- gfr between 60 to 89
stage 3-3a.eGFR 45TO<60
3b.eGFR 30 TO<45 |
|
| ExclusionCriteria |
| Details |
1.post renal transplant.
2. known case of HIV patients or subjects or subjects on immune suppressive drug.
3. pregnant and lactating femeles |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To access the efficacy of bruhatyadi kwath on symptoms,e GFR,and Albuminuria in Chronic Kidney Disease.
2.To access the efficacy of bruhtyadi kwath with furosemide on symptomes, eGFR and albuminuria chronic Kidney disease.
3.To access the efficacy of furosemide on symptoms, eGFR And albuminuria in chronic kidney disease
4.To compare the effect of above therapy in various stages of chronic kidney disease. |
Assessment will be reported on baseline, 30th day, 60 th day,&90th day on the basis of subjective & objective parameters |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3 |
|
Date of First Enrollment (India)
|
20/07/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/11/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
in process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
current study is the double blind randomized controlled clinical trial. purpose of study: Chronic kidney disease (CKD) is a global health problem that costs health systems a lot of money, and also a risk factor for cardiovascular disease (CVD). CKD is linked to an increased risk of cardiovascular morbidity, premature mortality, and/or a lower quality of life at all stages. In modern science management of Chronic kidney disease. mainly includes supportive treatment, use of diuretics and in severe cases dialysis or renal transplant. But all these treatment has their own limitations like high cost, adverse effects as well as complications. In Ayurveda many herbal formulations having Mutral (diuretic) and Rasayana (rejuvenating) properties are recommended in the management of Mutravikaras like Mutraghata (chronic kidney disease). Various research studies conducted on herbal drugs in mutravikaras are available showing their efficacy 7,8,9. BruhtyadiKwath possesses diuretic, rejuvenating, antibacterial and anti-inflammatory properties. Research studies are conducted on Bruhatyadikwath in the management of Mutrakruchra but no study conducted on Mutraghata. So for early stage prevention and to check further progression this study is planned along with furosemide to evaluate the efficacy of BruhtyadiKwathfor improving e-GFR and Albuminuria in Chronic Kidney Disease. |