| CTRI Number |
CTRI/2023/08/056532 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
13/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare effect of Dhatryadi Kwath and Trunapanchmoola Kwath in urinary tract infection |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the efficacy of Dhatryadi Kwath and Trunapanchmoola Kwath in management of Pittaj Mutrakruchchra 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 Pradnya Shukracharya Kolhal |
| Designation |
Post Graduate Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Hospital and Research Centre Ashta |
| Address |
OPD No 13 Shalyatantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8411897251 |
| Fax |
|
| Email |
pradnyakolhal11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akbar Walandkar |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Hospital and Research Centre Ashta |
| Address |
3rd floor Department of Shalyatantra Hon Shri Annasaheb Dange Ayurved Medical College and Research Centre Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860181980 |
| Fax |
|
| Email |
akbar.walandkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akbar Walandkar |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Hospital and Research Centre Ashta |
| Address |
3rd floor Department of Shalyatantra Hon Shri Annasaheb Dange Ayurved Medical College and Research Centre Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860181980 |
| Fax |
|
| Email |
akbar.walandkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Pradnya Shukracharya Kolhal |
| Address |
OPD No 13 Shalytantra OPD Ground Floor Dhanvantari Hospital Ashta Tal Walwa Dist 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 Pradnya Shukracharya Kolhal |
Hon Shri Annasaheb Dange Ayurved Medical College and Dhanvantari Ayurved Hospital Ashta |
OPD No 13 Shalyatantra OPD Ground floor Dhanvantari Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA |
8411897251
pradnyakolhal11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College and Research Centre Ashta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N309||Cystitis, unspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhatryadi Kwath, Reference: Bhaishajya Ratnawali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trunapanchmoola Kwath, Reference: Bhaishajya Ratnawali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient having signs and symptoms of Pittaj Mutrakruchchra according to subjective and objective criteria will be randomly selected
2 Patients irrespective of Gender Economic class Caste Race Religion |
|
| ExclusionCriteria |
| Details |
1 Urinary Tract Infection associated with Calculus which need surgical intervention
2 Patient having Malignancy Benign Prostate Hyperplasia Pyelonephritis Uncontrolled Diabetes mellitus and Traumatic causes
3 Pregnant women and lactating mother
4 Neurological diseases causing Urinary Retention presence of foreign bodies such as indwelling catheters other drainage devices
5 Chronic kidney disease Renal failure renal transplant patient |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Dhatryadi Kwath and Trunapanchmoola Kwath in Pittaj Mutrakruchchra |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of Dhatryadi Kwath & Trunapanchmoola Kwath in Pittaj Mutrakruchchra |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
30/08/2023 |
| 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
|
As we see the number of patients with Pittaj Mutrakruchchra are increasing now a days so this study will help the patients for better and early management The efficacy of Dhatryadi Kwath and Trunapanchmoola Kwath will be compared in the management of Pittaj Mutrakruchchra with special reference to Urinary Tract Infection Both the drugs will be given orally in the form of kwath in diagnosed cases of Pittaj Mutrakruchchra for seven days and as per need Last follow up will be done on seventh day 42 patients in each group will be studied Outcome of study will be assessed on reduction in symptoms of Pittaj Mutrakruchchra |