| CTRI Number |
CTRI/2020/11/029119 [Registered on: 13/11/2020] Trial Registered Prospectively |
| Last Modified On: |
09/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study held to see the effect of intake of Dhatryadi decoction in the treatment of infection in urinary tract |
|
Scientific Title of Study
|
Single Arm Clinical Study to Evaluate the Effect of Dhatryadi Kashaya in Pittaja Mutrakricchra |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Rajesh Pote |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr D Y Patil College Of Ayurved And Research Centre Pimpri Pune |
| Address |
Department of Kayachikitsa Opd no. 5 Dr D Y Patil College Of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
7743886706 |
| Fax |
|
| Email |
anjupote@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Digambar Dipankar |
| Designation |
MD Kayachikitsa |
| Affiliation |
Dr D Y Patil College Of Ayurved And Research Centre Pimpri Pune |
| Address |
Department of Kayachikitsa Opd no. 5 Dr D Y Patil College Of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9822279321 |
| Fax |
|
| Email |
drdgdipankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Rajesh Pote |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr D Y Patil College Of Ayurved And Research Centre Pimpri Pune |
| Address |
Department of Kayachikitsa Opd no. 5 Dr D Y Patil College Of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
7743886706 |
| Fax |
|
| Email |
anjupote@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Ayurved and Research Centre |
|
|
Primary Sponsor
|
| Name |
Anjali Rajesh Pote |
| Address |
Dr D Y Patil College Of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune |
| Type of Sponsor |
Other [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 |
| Anjali Rajesh Pote |
Dr D Y Patil College Of Ayurved And research Centre Pimpri Pune |
Opd no.5 and Ipd Kayachikitsa department Dr D Y Patil College Of Ayurved and Research Centre Sant Tukaram Nagar
Pimpri Pune
Maharashtra
India
Pune
MAHARASHTRA |
7743886706
anjupote@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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: Pittaja Mutrakricchra, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dhatryadi Kashaya Dose 40ml along with sugar Frequency Twice daily Route of Adminitration Oral Duration of therapy for 14 days |
Coarse powder of Dhatri Draksha Vidarikanda Yashtimadhu Gokshura each 4gm Boiled with 320 ml water reduced to 40 ml Patient will be asked to sieve it and consumed after it is cooled down along with 4gm of sugar This will be advised to take twice a day for the period of 14 days. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Selection of patient will be irrespective of gender, religion and socio-economical class.
2) Patients with the symptoms like painful micturition, burning micturition, hesitancy, urgency of urine will be selected.
3) Patients who are willing to enroll in the research and sign the consent form. |
|
| ExclusionCriteria |
| Details |
1)Patients with sepsis and renal failure, all immuno-compromised patients will be excluded.
2) Known pregnant women will be excluded.
3)Patients of diabetes mellitus will be excluded.
4)Urethral stricture.
5)Prostatomegaly |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dhatryadi Kashaya is effective in the management of Pittaja Mutrakricchra |
14 days study with 2 follow ups(0,7,14 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
16/11/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study to see the effectiveness of Dhatryadi Kashaya in the management of Pittaja Mutrakricchra. The study will be conducted with 32 patients showing signs and symptoms of Pittaja Mutrakricchra, they will be administered with Dhatryadi Kashaya twice a day along with 4gm of sugar for 14 days and follow up will be done on 7 and 14 days and conclusion will be drawn on the basis of proper statistical methods. |