| CTRI Number |
CTRI/2026/01/100050 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
benefits of Ayurvedic enema in CKD |
|
Scientific Title of Study
|
an open label control clinical study to evaluate the efficacy of trinpanchamool kwath siddha basti in Chronic kidney disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHANU PRIYA KAUSHIK |
| Designation |
PhD SCHOLAR |
| Affiliation |
SHRI KRISHNA AYUSH UNIVERSITY KURUKSHETRA HARYANA |
| Address |
Dept. OF Panchakarma,
PhD scholar room
shri krishna AYUSH university
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7838759934 |
| Fax |
|
| Email |
vaidyabhanu22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR ASHISH MEHTA |
| Designation |
PROFESSOR |
| Affiliation |
SHRI KRISHNA AYUSH UNIVERSITY KURUKSHETRA HARYANA |
| Address |
DEPT OF PANCHAKARMA
SHRI KRISHNA AYUSH UNIVERSITY KURUKSHETRA
Kurukshetra
HARYANA
136118
India |
| Phone |
8950375285 |
| Fax |
|
| Email |
drashishhmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ABHISHEK SAXENA |
| Designation |
associate professor |
| Affiliation |
MOTHERHOOD AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Dept. Of Panchakarma
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9528864005 |
| Fax |
|
| Email |
drabhishekmd7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Gurukul Ayurveda College, Haridwar, Uttarakhand, India, 249404 |
|
|
Primary Sponsor
|
| Name |
Bhanu Priya Kaushik |
| Address |
GOVT. GURUKUL Ayurveda College, Haridwar, Uttarakhand, India 249404 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harish Basera |
Govt. Doon Medical college |
Dept of Nephrology
Patel Nagar
248001
Dehradun
UTTARANCHAL |
9897408643
harishbasera@yahoo.com |
| Dr Uttam Kumar Sharma |
Gurukul Ayurveda College |
Dept of Panchakarma
Near gate 5 Gurukul Vishwavidhalaya 249404
Hardwar
UTTARANCHAL |
9411149479
druksm27@gmail.com |
| Dr Bhanu Priya Kaushik |
Motherhood Ayurveda Medical College and Hospital, Roorkee, Haridwar, India 247661 |
Dept of Panchakarma
Hardwar
UTTARANCHAL |
07838759934
vaidyabhanu22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| IEC GOVT. DOON MEDICAL COLLEGE AND HOSPITAL |
Approved |
| INSTITUTIONALETHICSCOMMITTEE |
Approved |
| INSTITUTIONALETHICSCOMMITTEE |
Approved |
| INSTITUTIONALETHICSCOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N182||Chronic kidney disease, stage 2 (mild). Ayurveda Condition: VRUKK, |
|
|
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 siddhi sthan , Procedure details: yoga basti -administration of medicine through anal route as told by acharya)
(1) Medicine Name: trinpanchamool kwath siddha basti, Reference: mutrakrichra roga adhikar chakradatta, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of CKD or patients having clinical sign and symptoms of CKD
Clinically stable patients of stage 1 to stage 3
Patients having Serum Creatinine level between 1.4mg/dl to ≤ 5mg/dl
Age group between 20- 65 yearS
Patient fit for basti karma and willing to participate in clinical trial.
Nondiabetic and if Diabetic- HbA1c in % less than 7.0
|
|
| ExclusionCriteria |
| Details |
Stage: Patient of any stage requiring dialysis/ who is already on dialysis
Patient with severe toxicity
Patient with End stage renal disease (ESRD)
Patient having poly cystic kidney or any other kidney disorder
Patient with autoimmune or genetic disorder or carcinoma
Pregnant female and lactating mother
Patient having serious systemic disorders (like chronic heart disease etc)
Patient with hypertension ≥150/100 mmHg
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 reducion in biomarkers (serum createnine, bloodurea and eGFR) of CKD |
1 reducion in biomarkers (serum createnine, bloodurea and eGFR) of CKD 48 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of the trinpanchamool kwath siddha Basti in reduction of Subjective Parameters/symptoms |
48 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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 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
|
Chronic Kidney Disease (CKD), is a condition in which kidney function gradually detoriates over months or years. The world is facing a global epidemic of Chronic Kidney Disease. There are several conservative therapeutic options available in modern medicines, each with its own set of advantages and disadvantages. CKF treatment is an organ based, and there are only two conservations measures: dialysis and kidney transplantation, according to present research. Dialysis is not a treatment for renal failure; it may prolong life but does not cure it. Kidney transplantation is a very expensive procedure and patient must take extremely expensive immunosuppressive medicines for the rest of his or her life, which destroys the body defense system.In India, prevalence of kidney disease is increases due to sedentary life style, eating habits, hypertension, and uncontrolled diabetes. Hence there is an alarming need of some alternate approach which is safe and effective in management of CKD, therefore this study has been taken to apply ayurveda principals on CKD, with growing number of cases of CKD and keeping in mind the available conventional line of treatment and its financial burden on patient, ayurveda through its holistic line of management.The formulation(Trinpanchamool) used in this study have been included in the mootra virechaniya mahakashaya by acharya charak. They are capable of treating many disorders related to the urinary system. This kwath has vata-pitta shamak property, is diuretic, kidney stimulant, and hematopoietic in action. Trinapanchamoola kwath not only reduces the fuild overload due to renal impairment by diuretic action but also strengthen the renal system.panchakarma procedure "Basti karma" is very much effective to expel the dosas out of the body and also works well in urinary system and vata vikar. The present study is planned to evaluate the efficacy of trinpanchamool kwath siddha basti in CKD. There will be 2 groups in the study, Group A (control group) will be given modern line of treatment under supervission of nephrologist aand another group B will be given Trinpanchammol kwath siddha basti in 2 courses of yog basti (8 days).The parameters- serum cretinine, bloodures, e-GFR, Hb% will be noted before (zero day),during(9th, 25th,34th day) and after the treatment(49th day). 2 Followups will be done on day 64 &79th day. the data collected will be statistically analysed and will be presented in the form of dissertation. |