| CTRI Number |
CTRI/2024/12/078557 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the effect of bhumyamalaki kwath in mutrakruchhra with urine examination examination |
|
Scientific Title of Study
|
Single arm clinical study to assess the effect of bhumyamalaki kwath in mutrakruchhra with special reference to urine routine and microscopic examination |
| 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 Jyotsna Raghunath Payamal |
| Designation |
PG Scholar Rognidan |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Islampur |
| Address |
Department of Rognidan Division
No 1 Room no 1
Sangli
MAHARASHTRA
415409
India |
| Phone |
9922233041 |
| Fax |
|
| Email |
jyotsna010996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Mahavir Khot |
| Designation |
Reader |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Islampur |
| Address |
Department of Rognidan Division
No 1 Room no 1 tal Walwa Dist Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
91727100913 |
| Fax |
|
| Email |
drabhay1988khot@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Mahavir Khot |
| Designation |
Reader |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Islampur |
| Address |
Department of Rognidan Division
No 1 , Room no 1 tal Walwa Dist Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
91727100913 |
| Fax |
|
| Email |
drabhay1988khot@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital and Research Centre, Islampur. taluka Walwa Dist
Sangli State Maharashtra Country India Pincode 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Jyotsna Raghunath Payamal |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute
and Research Centre Islampur Sangli |
| Type of Sponsor |
Other [Self] |
|
|
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 Jyotsna Raghunath Payamal |
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur |
Department of
Rognidan , Division no.
1 Room no 1
Sangli
MAHARASHTRA |
9922233041
jyotsna010996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N390||Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhumyamalaki , Reference: Raj Nighantu , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -Bhumyamlaki churna will be purchased from GMP certified company.Bhumyamlaki Churna will be given to patient and kwath preparation procedure will be explained as per sharangdhar samhita. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients irrespective of their religion, profession, socioeconomic and marital status will be included in study.
Patients with signs and symptoms of mutrakruchhra as per samhitas will be included. |
|
| ExclusionCriteria |
| Details |
Age group below 18years and above 60years.
Known case of chronic kidney diseases like renal tuberculosis,acute glomerulo nephritis,renal failure, nephritic syndrome also patients with congenital abnormalities, known case of benign prostatic hyperplasia, diabetes mellitus, patients with history of systemic illnesses like endocrine disorders, immunodeficiency disorders like AIDS.
Patients of sannipatik,purishaj,ashmarij,shukraj,abhighataj,sharkaraj mutrakruchhra.
Women which are in Antenatal care(ANC) and Postnatal care(PNC) state. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of bhumyamalaki kwath in mutrakruchhra with special reference to urine routine and microscopic examination. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the ayurvedic aspect of mutrakruchhra vyadhi in detail.
2.To study the urinary tract infection as per modern science.
3.To study the bhumyamalaki kwath in detail.
4.To study the urine routine and microscopic examination in detail.
5.To study the effect of bhumyamalaki kwath on signs and symptoms of mutrakruchhra along with changes in urine routine and microscopic examination. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/01/2025 |
| 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
|
The use of antibiotics in modern medicine has made it simpler to treat urinary tract infections, but the risks of reinfection and recurrence remain serious issues. Additionally, a significant problem is the emergence of resistance. Bhumyamalaki dravya effective in treating mutrarogas according to Raj Nighantu. According to rogaghnata of bhumyamalaki dravya it will be better choice in the management of mutrakruchhra. Bhumyamalaki contains ras- tikta kashay madhur vipak- madhur virya- sheet guna- laghu ruksha dhoshghnata- kaphpittashamak. These properties are against almost all 3 doshas which are parts of samprapti ghatak of mutrakruchhra vyadhi i.e. dosha- pittapradhan tridosha; dushya- ras dhatu (kleda); strotas- mutravaha strotas; agni- rasagni mandya. Also compounds of phyllanthin and hypophyllanthin which are chemical constituents of bhumyamalaki shows antimicrobial activity. Hence, I choose bhumyamalaki dravya to evaluate it’s effect in mutrakruchhra. |