| CTRI Number |
CTRI/2026/03/105159 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
“Effect of Viratarvadi Kwath with Shuddh Shilajeet over
Varunadi Kwath with Gokshuradi Guggulu, among patients who are on standard care in
management of Mutraghata (~Chronic Kidney Disease up to Grade 3b), an Open-label,
Randomized Comparative Clinical Trial” |
|
Scientific Title of Study
|
A Randomized Open-Label Comparative Clinical Trial Evaluating the Efficacy of Viratarvadi Kwath with Shuddha Shilajeet versus Varunadi Kwath with Gokshuradi Guggulu as Add-on Therapy in the Management of Mutraghata (Chronic Kidney Disease up to Grade3b) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muskan Goyal |
| Designation |
MD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of kayachikitsa, 6th floor, Academic block,All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi,India
South
DELHI
110076
India |
| Phone |
7838329627 |
| Fax |
|
| Email |
muskangoel1908@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Muskan Goyal |
| Designation |
MD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of kayachikitsa, 6th floor, Academic block,All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi,India
South
DELHI
110076
India |
| Phone |
7838329627 |
| Fax |
|
| Email |
muskangoel1908@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Muskan Goyal |
| Designation |
MD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of kayachikitsa, 6th floor, Academic block,All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi,India
South
DELHI
110076
India |
| Phone |
7838329627 |
| Fax |
|
| Email |
muskangoel1908@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda,Gautampuri,Sarita Vihar, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda,Gautampuri,Sarita vihar, New
Delhi-110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Muskan Goyal |
All India Institute of Ayurveda |
Dept of Kayachikitsa, 6th Floor , Academic & Research Block
South
DELHI |
7838329627
muskangoel1908@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIA - Division of Translational Research & Biostatistics |
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). Ayurveda Condition: MUTRAGHATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Viratarvadi Kwath, Reference: Ashtang Hridaya,Sutra Sthana, Shodhanadigana sangraha adhayay 15, verses24-25, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Shuddh Shilajeet, Reference: Chakradatta, Mutraghata chikitsa adhyaya, shlok-8, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Varunadi Kwath, Reference: Chakradutta,Trimarmiya chikitsa(Ashmari chikitsa), shlok 18-21, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Gokshuradi Guggulu, Reference: Sharangdhara Samhita, Madhyama Khaṇḍa, Adhyaya 7 (verses 84–86), Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of all genders.
Patients diagnosed with signs and symptoms of chronic kidney disease as per standard KDIGO criteria of known etiology, including diabetic nephropathy, hypertensive nephrosclerosis, chronic glomerulonephritis, or hereditary causes such as autosomal dominant polycystic kidney disease ADPKD shall be included.
Patient presenting with symptoms of Mutraghata. The NAMASTE Portal, having serial no. 1258, the morbidity code EJ 3, corresponds to Mutraghata.
Patients of the age group 21 to 65 yrs. with confirmed diagnosis of stage up to G3B as per standard KDIGO CRITERIA, eGFR greater than 30 ml per min. per 1.73 m² and less than 60 ml per min. per 1.73 square meters not having undergone RRT were included.
Subjects who are willing to sign the informed written consent.
Subjects who are not registered in any other research project in the last 12 weeks. |
|
| ExclusionCriteria |
| Details |
1.HIV-associated nephropathy and transplant allograph failure
2.Renal Artery stenosis.
3.Neoplasm of Kidney.
4.History of previous kidney transplant.
5.Patients of Congenital Renal Diseases like Autosomal dominant and Recessive Polycystic Kidney disease, Congenital Nephrotic syndrome (Finnish type), Alport’s syndrome, Fabry,s disease and juvenile Nephronophthisis.
6.Patients with clinically diagnosed cardiorenal syndromes, including those with congestive heart failure, ischemic heart disease with reduced ejection fraction ,or acute or chronic cardiac conditions significantly contributing to renal dysfunction, shall be excluded from the study.
7.Uncontrolled diabetes HbA1C greater than 9 percentage and uncontrolled HTN greater than 160/100mmHg.
8.Patients suffering from Tuberculosis, Malignancy, Pregnancy and lactation, or any other systemic illness.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Viratarvadi Kwath with Shuddh Shilajeet over Varunadi Kwath with Gokshuradi Guggulu in the management of Mutraghataa (Chronic Kidney Disease up to grade 3B) based on Improvement in the Serum Creatinine, eGFR , Hb levels and Urine albumin |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)Improving Serum Urea, BUN level, and Serum Electrolytes level. |
4 weeks |
2)Improving classical signs and symptoms of Mutravaha Stroto Dushti
1).Atishrita-atibaddam-Alpo-alp mutra Bahal mutra
2.Shwaskricchta
3.Raktalpata-Pandutvam
4.Aksikut-mukha-pada Shavyathu
5)Dhatukashya
|
4 weeks |
| 3)Improving Quality of Life (Kidney Disease and Quality of Life -KDQOL-36). |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
01/04/2026 |
| 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 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 study is an open-label, randomized comparative clinical
trial designed to evaluate the effectiveness of two Ayurvedic treatment
regimens in patients of Mutraghata (correlated with Chronic Kidney Disease
up to Grade 3b) who are already receiving standard conventional care. The
trial compares Viratarvadi Kwath with Shuddh Shilajeet against Varunadi
Kwath with Gokshuradi Guggulu to assess their relative therapeutic benefits
in improving clinical outcomes and kidney function.
Participants in the control group receive Varunadi Kwath
(30 ml twice daily before food) along with Gokshuradi Guggulu (500 mg
twice daily before food), while the trial group receives Viratarvadi
Kwath (30 ml twice daily before food) combined with Shuddh Shilajeet
(250 mg twice daily before food).
The total study duration 4 weeks.The study aims to generate
comparative evidence on the efficacy of these classical Ayurvedic formulations
as adjunct therapy in the management of early to moderate CKD. |