| CTRI Number |
CTRI/2023/10/058892 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
17/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study of Gokshuradi Guggulu prepared with two types in patients of urinary tract infection( mutrakriccha) |
|
Scientific Title of Study
|
A comparative pharmaceutico analytical & clinical study of Gokshuradi Guggulu prepared with two types of Guggulu shodhana & its effect on Mutrakriccha w.s.r. to UTI |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Parmar |
| Designation |
MD Scholar |
| Affiliation |
Post graduate training and research institute Government Ayurvedic College, Patiala |
| Address |
PG Department of Rasa shastra and bhaishajya kalpana, Post graduate training and research institute Government Ayurvedic College, Patiala
PUNJAB
147001
India
Patiala
PUNJAB
147001
India |
| Phone |
9754394006 |
| Fax |
|
| Email |
rohitparmar044@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek |
| Designation |
Lecturer |
| Affiliation |
Post graduate training and research institute Government Ayurvedic College, Patiala |
| Address |
PG Department of Rasa shastra and bhaishajya kalpana, Post graduate training and research institute Government Ayurvedic College, Patiala
Patiala
PUNJAB
147001
India |
| Phone |
8310409168 |
| Fax |
|
| Email |
abhi.gehlot04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek |
| Designation |
Lecturer |
| Affiliation |
Post graduate training and research institute Government Ayurvedic College, Patiala |
| Address |
PG Department of Rasa shastra and bhaishajya kalpana, Post graduate training and research institute Government Ayurvedic College, Patiala
Patiala
PUNJAB
147001
India |
| Phone |
8310409168 |
| Fax |
|
| Email |
abhi.gehlot04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College Patiala punjab |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College |
| Address |
Government Ayurvedic College, Patiala, Punjab
147001 |
| Type of Sponsor |
Government 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 Rohit Parmar |
Government Ayurvedic Hospital, Patiala, Punjab |
Room no. 16, Ground floor Department of Shalya tantra, Government Ayurvedic Hospital, Patiala, Punjab, 147001
Patiala
PUNJAB |
9754394006
rohitparmar044@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Govrnment Ayurvedic College, Ptaiala, Punjab, no. 4680 |
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: Gokshuradi guggulu, Reference: sharangdhara samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: sukhushna jala), Additional Information: in this, guggulu shodhana is done with guduchi kwatha | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi guggulu , Reference: sharangdhara samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: sukhushna jala), Additional Information: in this, guggulu shodhana is done with triphala kwatha |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. patients presenting with the sign and symptoms of Mutrakriccha w.s.r. UTI
2. patients who are giving consent to study. |
|
| ExclusionCriteria |
| Details |
1. patients with STD( sexually transmitted diseases.
2. if congenital anomaly of kidney, ureter, urinary bladder, or urethra.
3. patients with systemic disorders like hypertension , tuberculosis etc.
4. lactating mother or pregnant women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameter- grading will be done with the signs and symptoms of mutrakriccha i.e uti
urine routine & microscopic, Hb , TLC ,DLC, ESR, SGOT/SGPT,S. CREATININ, UREA |
After 21 days intervenetion of gokshuradi guggulu orally and 10 days after stopping the medicine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Grading will be done with signs & symptoms of mutrakriccha
urine routine & microscopic
Hb
TLC
DLC
ESR
SGOT SGPT
SERUM CREATININ
UREA |
After 21 days intervenetion of gokshuradi guggulu orally & 10 days after stopping the medicine |
|
|
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)
|
05/11/2023 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
in this trial we are selecting patients of urinary tract infection separately in two groups ( on the basis of medicine prepared with two different methods ) in which we will do interventional study with Gokshuradi Guggulu ( prepared with two different methods ) administered to the patients in the form of tablets with dose of 2 tablets of 500 mg TDS. Assessment will be done on the subjective and objective parameters. route of administration- oral follow up on day 10 while taking medicine. |