| CTRI Number |
CTRI/2017/11/010449 [Registered on: 10/11/2017] Trial Registered Prospectively |
| Last Modified On: |
21/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL STUDY ON NIMBATVAK KVATHA AND GOKSHURADI GUGGULU IN THE MANAGEMENT OF MUTRAKRUCCHRA WITH SPECIAL REFERENCE TO URINARY TRACT INFECTION |
|
Scientific Title of Study
|
A CLINICAL STUDY ON NIMBATVAK KVATHA AND GOKSHURADI GUGGULU IN THE MANAGEMENT OF MUTRAKRUCCHRA WITH SPECIAL REFERENCE TO URINARY TRACT INFECTION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Milankumar M Bambhaniya |
| Designation |
PG scholar |
| Affiliation |
J S Ayurved Mahavidyalaya |
| Address |
J S Ayurved Mahavidyalaya College Road Nadiad 387001
J S Ayurved Mahavidyalaya College Road Nadiad 387001
Kheda
GUJARAT
387001
India |
| Phone |
9737812555 |
| Fax |
|
| Email |
bambhaniyamilan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish v patel |
| Designation |
Professor |
| Affiliation |
J S Ayurved Mahavidyalaya |
| Address |
J S Ayurved Mahavidyalaya College Road Nadiad 387001
J S Ayurved Mahavidyalaya College Road Nadiad 387001
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milankumar M Bambhaniya |
| Designation |
PG scholar |
| Affiliation |
J S Ayurved Mahavidyalaya |
| Address |
J S Ayurved Mahavidyalaya College Road Nadiad 387001
J S Ayurved Mahavidyalaya College Road Nadiad 387001
Kheda
GUJARAT
387001
India |
| Phone |
9737812555 |
| Fax |
|
| Email |
bambhaniyamilan@gmail.com |
|
|
Source of Monetary or Material Support
|
| J S Ayurved Mahavidyalaya College Road Nadiad 387001 |
|
|
Primary Sponsor
|
| Name |
J S Ayurved Mahavidyalaya |
| Address |
J S Ayurved Mahavidyalaya College Road Nadiad 387001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Bambhaniya Milankumar |
P D Patel Ayurvedic Hospital Nadiad |
college road Nadiad
Kheda
GUJARAT |
9737812555
bambhaniyamilan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committe for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Urinary tract infection patient, (1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nimbatvak Kvatha (decoction),Gokshuradi Guggulu(tablet) |
decoction 40ml/3time per day,tablet 3tab/3time per day |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having the signs and symptoms of mutrakrcchra (urinary tract infection) with more than five pus cells in urine.
2.Patients of both sexes having age between 18 to 50 years. |
|
| ExclusionCriteria |
| Details |
1.Urinary tract infections due to or associated with other clinical conditions i.e. BPH, urethral stricture, during menstruation period, interstitial cystitis, urolithiasis, renal disorders, other uropathies and leucorrhoea.
2.Patients having other co-morbidity i.e. cardio-vascular disorders, cancer, diabetes mellitus etc.
3.Patients having recurrent history of urinary tract infection and had more than or 2 time infections in last 2 months.
4.Patients having hyperpyrexia (>105â—¦F body temperature), septicemia and other complications of the urinary tract infections. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Ayurvedic Management in the patient of Urinary Tract Infection |
Effect of Ayurvedic Management in the patient of Urinary Tract Infection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2017 |
| Date of Study Completion (India) |
09/08/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
AYU journal
Manuscript no.: AYU_132_19 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Clinical evaluation of effectiveness of Ayurvedic Management in Urinary tract infection is the main object of study. Patient will be selected from P.D.Patel Ayurvedic Hospital, Nadiad after the confirmation of the patient of the Urinary tract infection with the help of classical sign and symptoms, they were treated with following therapy: 1. Nimbatvak kvath (Ingredient- Nimba) Orally 40 ml 3 times in a day before food. 2. Gokshuradi Guggulu (Compound Ayurvedic Preparation: Gokshur + Guggulu + Haritaki + Bibhitaki + Amalaki + shunthi + Marich + Pippali + Musta) Orlly 3 tablets (each one is 300 mg) 3 times in a day after food with warm water. result In the area of results
both subjective and objective criteria was assessed and concluded by proper
statistical test. In subjective parameters, patients got result from 55.23% up to
96.66% in some symptoms with inclusion of chief complaints and associated
symptomatology. As per laboratory investigations, there were 3 parameters out
of them 2 were normal before and after the trial period, so, 1 were analyzed.
They shows significant results starting from 86.36% upto 100.00%. As an overall effect of the
treatment, 38.88% of patients had marked response whereas 61.11% of patients moderately
responded. |