| CTRI Number |
CTRI/2024/07/070590 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of effect of Gokshur kwath and Yavakshar in recurrent urinary tract infections and to study its antimicrobial effect |
|
Scientific Title of Study
|
Randomized controlled trial and assessment of antimicrobial effect of Gokshur kwath and Yavakshar in mootrakrichchhra with special reference to recurrent urinary tract infections. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smita Pandey |
| Designation |
Junior Resident |
| Affiliation |
BHU |
| Address |
Department of Shalya Tantra Faculty of Ayurveda IMS BHU Varanasi Sir Sunderlal Hospital faculty of Ayurveda IMS BHU Varanasi UTTAR PRADESH
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7860055603 |
| Fax |
|
| Email |
smitapandeyvns65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Awadhesh Kumar Pandey |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalya Tantra Faculty of Ayurveda IMS BHU Varanasi Sir Sunderlal Hospital faculty of Ayurveda IMS BHU Varanasi UTTAR PRADESH
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7376887965 |
| Fax |
|
| Email |
awadheshoct20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Kumar |
| Designation |
Associate Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Microbiology
Faculty of Modern Medicine
Institute of Medical Sciences
Banaras Hindu University
Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451354332 |
| Fax |
|
| Email |
deepakkumar.micro@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital Faculty of Ayurveda Institute of Medical Sciences IMS BHU Varanasi 221005 Uttar Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Department of Shalya Tantra Faculty of Ayurveda Insitute of Medical Sciences |
| Address |
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005
India
|
| 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 Awadhesh Kumar Pandey |
Sir Sundarlal hospital BHU |
OPD No.12,14,16A Indian Medicine Wing
Department of Shalya Tantra Faculty of
Ayurveda Institute of Medical Sciences
BHU Varanasi UTTAR PRADESH
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
7376887965
awadheshoct20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Medical Sciences, Banaras Hindu University |
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: yavakshar, Reference: bhaishajya ratnavali chapter no 34 verse no 19, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -gokshura kwath), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: gokshur, Reference: bhaishajya ratnavali chapter no. 34 and verse no. 19, , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -yavakshar 500 mg capsule BID is given along with gokshur kwath | | 3 | Comparator Arm (Non Ayurveda) | | - | NITROFURANTOIN | Standard modern medication will be administered i.e. Nitrofurantoin 100mg 1 T.D.S. for 15 days.
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult male and female subjects of age 18-60 yrs having symptoms of Mootrakrichchhra such as Bastishul (pain in lower abdomen)/Muhurmuhurmootrata(frequent micturition)/ Sadaahmootrata (burning micturition)/Krichchhrapravrutti of Mootravahana/ Sarujamootrata (painful micturition/dysuria)and with positive urine culture and sensitive to nitrofurantoin.
Patients having symptoms of recurrent Urinary tract infections i.e. 3 or more culture proven infections within a 12 months period, or as 2 or more culture proven infections in a 6 months period
Subjects willing to sign informed consent and follow the study procedure.
|
|
| ExclusionCriteria |
| Details |
Subjects having symptoms of mootraghat such as vibandh of mootra (obstructive flow of urine, saraktmootrata (gross hematuria), mootrasang (stricture of urethra)vatashthila (enlarged prostate).
Subjects of age group less than 18 years and more than 60 years.
Complicated Urinary tract infections like Catheterization, anatomic and functional abnormalities, immune suppression, renal disease, renal calculi, pyelonephritis, neurogenic bladder)
History of interstitial cystitis,bph,Urothelial cancer
Pregnancy
STDs ,Tuberculosis affecting the bladder.
HIV, Anti-HCV &, HBsAg positive subjects.
Patient suffering from any other systemic diseases
Uncontrolled Hypertension
Uncontrolled Diabetes mellitus
T.B
Malignancy
Patients with sterile urine specimen.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in symptoms like-
Bastishul (pain in lower abdomen)
Muhurmuhurmootrata(frequent micturition)
Sadaahmootrata (burning micturition) Krichchhrapravrutti of Mootravahana/ Sarujamootrata (painful micturition/dysuria) |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the antimicrobial effect of Gokshur Kwath and Yavakshar |
2 months |
|
|
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)
|
30/07/2024 |
| 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
|
Conventional antibiotics are the first choice in an acute episode of UTI; therefore, resistance of pathogenic bacteria to antibiotics is of high clinical concern. The concept of the control of drug resistance is rather widely held today. Therefore the world looks at some alternative and effective medicine particularly of natural origin. In Ayurvedic texts various acharyas mentioned the shodhana and Shaman chikitsa for it. The Gokshurkwath and Yavakshar are mentioned as mootrakrichchhrahara in Bhashajya Ratnavali. Hence, the present study aims to explore the efficacy of therapeutic and antimicrobial effect of Gokshurkwatha and Yavakshar in the management of mootrakrichchhra with special reference to recurrent Urinary tract infections. 60 cases of mootrakrichhra will be included in this interventional study which will be randomly divided into 2 groups of 30 patients in each group. One group will be prescribed gokshura kwath 40ml and yavakshar 500 mg BD for 30 days .Second group will be prescribed nitrofurantoin 100mg TDS for 15 days after doing urine culture and sesitivity .The study will be conducted for 60 days with 4 follow up after every 15 days. |