| CTRI Number |
CTRI/2025/01/079492 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of Chronic kidney disease |
|
Scientific Title of Study
|
A Clinical study to evaluate the efficacy of Niruha Basti alongwith Shamana Chikitsa in management of Chronic kidney disease - A single group pre-and post-design clinical study |
| 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 Khushaboo Kuldeepsingh Chauhan |
| Designation |
P G Scholar |
| Affiliation |
J.S. Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital |
| Address |
Department of Kayachikitsa, J S Ayurveda Mahavidyalaya, College road, Nadiad-387001
Kheda
GUJARAT
387001
India |
| Phone |
7016217137 |
| Fax |
|
| Email |
khushbooc011998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Manish Patel |
| Designation |
Professor and HOD Department of Kayachikitsa |
| Affiliation |
J.S. Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital |
| Address |
Department of Kayachikitsa, J S Ayurveda Mahavidyalaya, College road, Nadiad-387001
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Manish Patel |
| Designation |
Professor and HOD Department of Kayachikitsa |
| Affiliation |
J.S. Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital |
| Address |
Department of Kayachikitsa, J S Ayurveda Mahavidyalaya, College road, Nadiad-387001
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurved teaching pharmacy of J.S. Ayurveda Mahavidyalaya and P.D.Patel Ayurveda Hospital, Nadiad, Gujarat-387001 |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidyalaya |
| Address |
Department of Kayachikitsa, J S Ayurveda Mahavidyalaya, College road, Nadiad-387001 |
| Type of Sponsor |
Private medical college |
|
|
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 Khushaboo Kuldeepsingh Chauhan |
P D Patel Ayurveda Hospital |
Department of Kayachikitsa, J S Ayurveda Mahavidyalaya, College road, Nadiad-387001
Kheda
GUJARAT |
7016217137
khushbooc011998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MAGANBHAI ADENWALA MAHAGUJARAT UNIVERSITY-NADIAD |
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: MUTRAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charak samhita, Procedure details: 320 ml Punarnavadi Niruha Basti will be given to the patients on empty stomach everyday through procto-colonic route for duration of 4 weeks.)
(1) Medicine Name: Punarnavadi kwatha, Reference: bhaishajya ratnavali, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 320(ml), Frequency: od, Duration: 4 Weeks | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi Guggulu, Reference: Bhaishajya Ratnavali,Gulmachikitsa adhyaya (Chapter-32), Shloka no-39-41, Route: Oral, Dosage Form: Guggulu , Dose: 300(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varunadi Kwatha, Reference: Sarangdhara Samhita Madhyama Khanda, Chapter 7, Shloka no-84-87, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasayana Churna, Reference: Astangahrdayangama Uttarsthana, Chapter 39, Shloka -159, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: - | | 5 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhumyamalaki Churna, Reference: Bhavprakasha Nighantu, Guduchyadi Varga, 278, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients fulfilling the diagnostic criteria.
2.Patients having age between 18 to 65 years.
3.Patients with GFR level less than 60 ml/min/1.73
meter square and persistent (present for more
than 3 months), laboratory investigations (i.e.
raised serum
creatinine and blood urea level).
|
|
| ExclusionCriteria |
| Details |
1.Female patients having pregnancy, breast feeding
or post-delivery period.
2.Patients of end stage kidney disease.
3.Patients who are on dialysis treatment.
4.Patients who are having previous history of
renal transplantation.
5.Patients of hepato-renal insufficiency or renal
insufficiency due to hemodynamic circulatory
disorders and CCF.
6.Patients having comorbidities like cardio-
vascular diseases, psychological disorders,
serious acute organic diseases, liver disorders
or metabolic disorders etc.
7.Patients with any bleeding disorders.
8.Patients on steroid medications.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome will be relief in signs, symptoms and assessment will be done with the help of changes in Hb eGFR Serum Creatinine Blood Urea Serum Electrolytes (Sodium, Potassium, Chloride) Serum Calcium Serum Phosphate Urine Routine and Microscopic |
Baseline, 2 weeks and 4 weeks after discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/02/2025 |
| 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
|
Clinical evaluation of Ayurvedic management of Chronic kidney disease is the main objective of the study. Patients will be selected from P.D. Patel Ayurvedic Hospital, Nadiad after the confirmation of the patients of the Chronic kidney disease with the help of classical signs and symptoms, they will be treated with following therapy: 1. Punarnavadi Niruha Basti 2. Shamana Chikitsa |