| CTRI Number |
CTRI/2019/03/018132 [Registered on: 15/03/2019] Trial Registered Prospectively |
| Last Modified On: |
13/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Trial Of ‘Draksha Sharkar’ And ‘Darvi Amalaki Sharkar’ In ‘Pittaj Mootrakrichchhra’. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Evaluate Efficacy Of ‘Draksha Sharkar’ And ‘Darvi Amalaki Sharkar’ In ‘Pittaj Mootrakrichchhra’. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakesh Hingane |
| Designation |
Medicine Resident |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya OPD No 2 Kayachikitsa Department first floor Sane guruji arogya kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8975777566 |
| Fax |
|
| Email |
rakeshhingane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayashree N Tongaonkar |
| Designation |
Professor |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya OPD No 2 Kayachikitsa Department first floor Sane guruji arogya kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822829493 |
| Fax |
|
| Email |
jntayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh Hingane |
| Designation |
Medicine Resident |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya OPD No 2 Kayachikitsa Department first floor Sane guruji arogya kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8975777566 |
| Fax |
|
| Email |
rakeshhingane@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMs Sumatibhai Shah Ayurved Mahavidyalaya OPD No 2 Kayachikitsa Department first floor Sane guruji arogya kendra Malwadi Hadapsar Pune |
|
|
Primary Sponsor
|
| Name |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| 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 |
| Dr Rakesh Hingane |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya OPD No 2 Kayachikitsa Department first floor Sane guruji arogya kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
8975777566
rakeshhingane@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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Darvi Amalaki Sharkar |
20 ml BD (pragbhakta) for 5 days. |
| Intervention |
Draksha Sharkar |
20 ml BD (pragbhakta) for 5 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients presenting with cardinal symptoms of Pittaj mootrakrichchhra mentioned in Charak Samhita, chikitsasthan 26. Such as
1. Sapeetamutrapravrutti
2. Saraktamutra pravrutti
3. Muhurmuhu mutra pravrutti
4. Sadaha Mutrapravritti
5. Sashul Mutrapravritti
2) The patients will be selected irrespective of religion, occupation, economical status and marital status with informed written consent.
3) Patient having above 2 or more than complaints will be selected
|
|
| ExclusionCriteria |
| Details |
Diagnosed patient of
1. Uncontrolled Diabetes Mellitus and Known case of diabetes mellitus
2. TB
3. Renal failure.
4. Patient of chronic cystitis with bladder wall change.
5. Benign or malignant tumors of bladder
6. Known cases of HIV infection.
7. Known case of mutraghat, ashmari (renal, vesicular calculus), benign prostate hypertrophy, urethral stricture, phimosis, tumours, trauma to urogenital tract.
8. Congenital causes and Obstructive pathology
|
|
|
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 |
1) To assess the efficacy of ‘Draksha Sharkar’ in ‘Pittaj mootrakrichchhra’ by clinical parameter (Lakshana).
2) To assess the efficacy of ‘Draksha Sharkar’ in ‘Pittaj mootrakrichchhra’ by Routine examination of urine. |
5 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To develop evidence based research for efficacy of ‘Draksha Sharkar’ in ‘Pittaj mootrakrichchhra’
2. To generate data of good standardized drug of herbal origin with good efficacy and less side effects.
3. To study the changes in pH of urine with Draksha Sharkar. |
5 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
18/03/2019 |
| Date of Study Completion (India) |
30/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Randomized
Controlled Clinical Trial To Evaluate Efficacy Of ‘Draksha Sharkar’ And ‘Darvi Amalaki Sharkar’ In ‘Pittaj Mootrakrichchhra’. Primary : To assess the efficacy of ‘Draksha
Sharkar’ in ‘Pittaj mootrakrichchhra’ by clinical parameter
(Lakshana) and by Routine examination
of urine. Selection
of topic : This study is planned
to assess the efficacy of Draksha Sharkar
on pittaj mootrakrichchhra and to provide better option for its management. In
developing country disease has more prevalence due to poor personal hygiene,
mal nutrition, and environmental condition. Pittaj
mootrakrichchhra is a disease where ayurveda offer a better hand than any
other medical system. Scope of present work is limited upto pittaj mootrakrichchhra
only. Recurrence of disease is very common. Hence, this subject is considering
for study, to assess the efficacy of Draksha
Sharkar in pittaj mootrakrichchhra. considering all the above things the study will be carried out in comparison between two ayurvedic formulations. Patients will be divided into 2 groups containing 30 each. 1 group will be given Draksha Sharkar and other group will be given Darvi Amalaki Sharkar. Urine routine will be done on 1st and 5th day. Results and conclusion will be drawn from the observations made during the study.
|