| CTRI Number |
CTRI/2025/02/080465 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Evaluate the efficacy of Amritadi Kwath in the management of Mutrakricchra with special reference to urinary tract infection |
|
Scientific Title of Study
|
A Randomized open- label controlled clinical study to evaluate the efficacy of Amritadi Kwath in the management of Mutrakricchra with special reference to urinary tract infection |
| 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 Mohit khajuria |
| Designation |
PG Schollar |
| Affiliation |
Jammu institute of ayurveda and research |
| Address |
Department of kayachikitsa Jammu institute of ayurveda and research nardni raipur bantalab road jammu
Department of kayachikitsa Jammu institue of ayurveda and research nardni raipur bantalab road jammu
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9682360377 |
| Fax |
|
| Email |
mohitkhajuria100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Mahajan |
| Designation |
Professor |
| Affiliation |
Jammu institute of ayurveda and research |
| Address |
Department of kayachikitsa Jammu institue of ayurveda and research nardni raipur bantalab road jammu
Department of kayachikitsa Jammu institue of ayurveda and research nardni raipur bantalab road jammu
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9419119123 |
| Fax |
|
| Email |
drnitinmahajan1608@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Mahajan |
| Designation |
Professor |
| Affiliation |
Jammu institute of ayurveda and research |
| Address |
Department of kay8achikitsa Jammu institue of ayurveda and research nardni raipur bantalab road jammu
Department of kayachikitsa Jammu institue of ayurveda and research nardni raipur bantalab road jammu
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9419119123 |
| Fax |
|
| Email |
drnitinmahajan1608@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jammu institute of ayurveda and research nardni raipur bantalab road jammu and kashmir india 181123 |
|
|
Primary Sponsor
|
| Name |
Jammu institute of ayurveda and research |
| Address |
Jammu institute of ayurveda and research nardani raipur jammu jammu and kashmir India 181123 |
| 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 Mohit khajuria |
Jammu institute of ayurveda and research |
Department of kayachikitsa Jammu institute of ayurveda and research nardni raipur bantalab road jammu 181123
Jammu
JAMMU & KASHMIR |
9682360377
mohitkhajuria100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jammu institute of ayurveda and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: MUTRAKRUCCRAM, (2) ICD-10 Condition:N30-N39||Other diseases of the urinary system. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gudamalaki yoga, Reference: Chakardatta chapter 32 Mutrakricchradikar, Route: Oral, Dosage Form: Pishti, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amritadi Kwatha, Reference: Chakardatta chapter 32 Mutrakricchradikar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient representing sings and symptoms of mutrakricchra will be willing to participate in study.
subject willing to participate with written consent which will be conveyed in the language that the participant can understand. |
|
| ExclusionCriteria |
| Details |
patient suffering from diabetes mellitus, diabetes insipidus, pyelonephritis, uncontrolled hypertension, tuberculosis, renal disease, anatomical deformity, thyroid dysfunction, pelvic neoplasm, surgical history (phimosis), renal calculi, benign prostatic hyperplasia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sadaham mutra, Sarujam mutra, Muhurmuhur mutra |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in mutrakriccha(UTI) grading score. |
Baseline,30th,45th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
25/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Ayurveda is the oldest healing science which means the science of life . It emphasizes disease preventive aspects and helps maintain health through lifestyle modification and dietary changes. According to ayurveda, mutra is formed from kitta bhaag of ahara by the action of jathragni. In ayurveda urinary disorder come under mutravahasrrotasa and describe in the form of mutrakriccha and mutraghata. |