| CTRI Number |
CTRI/2025/06/088197 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"An Ayurvedic Approach to Managing Chronic Kidney Disease Using Dhanyakavarunadi Kwath and Tamalakyadi Churna" |
|
Scientific Title of Study
|
A clinical study of dhanyaka-varunadi kwath and tamalakyadi churna in tha management of chronic kidney disease w.s.r.to mutravahasroto dushti |
| 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 SURBHI JHA |
| Designation |
Post Graduation scholar |
| Affiliation |
Govt. Dhanwantari ayurvedic medical college and hospital |
| Address |
Kayachikitsa department OPD no.18 Govt. Dhanwantari ayurvedic hospital ujjain MP
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9584420810 |
| Fax |
|
| Email |
drsurbhijha1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Omprakash Vyas |
| Designation |
Proffessor |
| Affiliation |
Govt. Dhanwantari ayurvedic medical college and hospital |
| Address |
Department of kayachikitsa opd no.18 Govt. Dhanwantari ayurvedic hospital ujjain MP
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9713574021 |
| Fax |
|
| Email |
opvyas24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Omprakash vyas |
| Designation |
Proffessor |
| Affiliation |
Govt. Dhanwantari ayurvedic medical college and hospital |
| Address |
Department of kayachikitsa opd no.18 Govt. Dhanwantari ayurvedic hospital ujjain MP
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9713574021 |
| Fax |
|
| Email |
opvyas24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. autonomous Dhanvantari ayurvedic medical college and hospital Agar road ujjain mp india 456006 |
|
|
Primary Sponsor
|
| Name |
Govt Auto Dhanwantari ayurvedic medical college and hospital Ujjain |
| Address |
Chimangunj mandi Agar road Ujjain Madhya pradesh, India, Pincode-456006 |
| Type of Sponsor |
Government 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 surbhi jha |
Govt Dhanwantari ayurvedic college and hospital ujjain |
Govt Dhanwantari ayurvedic college and hospital Kayachikitsa department opd no 18 chimanganj mandi Agar road Ujjain MP 456006
Ujjain
MADHYA PRADESH |
9584420810
drsurbhijha1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee govt dhanwantari ayurvedic medical college ujjain |
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: MUTRAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Tamalakyadi churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Dhanyaka-varunadi kwath, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients confirmed diagnosis of chronic kidney disease were included.Patients with Stages 1,2,3a,3b and 4 laboratory investigations (i.e. raised serum creatinine and blood urea level) |
|
| ExclusionCriteria |
| Details |
1. Female patients having pregnancy lactating mothers.
2. Patients with end-stage renal failure.
3. Patients who have been on dialysis treatment for more than 1 month. Patients who are already operated for renal transplantation and then have nephropathy.
4. Patients of hepato-renal insufficiency or renal insufficiency due to hemodynamic circulatory disorders and CCF.
5. Patients of diabetic nephropathy.
6. Patients with serious illnesses like cardiovascular diseases, acute mental disorders, serious chronic co-morbidity, hypo or hyperthyroidism, liver or metabolic disorders, etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms of chronic kidney disease |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effective management of chronic kidney disease by relieving symptoms. |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
20/06/2025 |
| 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="0"
Months="6"
Days="29" |
|
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
|
This is randomised interventional study of Dhanyaka-varunadi kwath and Tamalakyadi churna in CKD w.s.r. to Mutravahastrotodushti. Total 45 patients will be enrolled in present study selected patients will be decided into three groups. Group A containing of 15 patients will be given Dhanyaka-varunadi kwath and group B 15 patients will be given Tamalakyadi churna and group C 15 patients will be given both Dhanyaka-varunadi kwath and Tamalakyadi churna. Follow up will be on every 15 days. |