| CTRI Number |
CTRI/2024/03/064753 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of uttarbasti in urethral stricture |
|
Scientific Title of Study
|
An assessment of effect of dhanyak gokshur ghrita uttarbasti in mutra marg sankoch w.s.r to urethral stricture-open clinical trial |
| 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 Namrata Lubal |
| Designation |
PG scholar |
| Affiliation |
Dr G D pol foundation YMT ayurvedic medical college and hospital |
| Address |
3rd floor shalyatantra department Dr G D pol foundation YMT ayurvedic medical college and hospital PG Institute sector 4 kharghar Navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8605610892 |
| Fax |
|
| Email |
namratalubal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Yadav |
| Designation |
Professor |
| Affiliation |
Dr G D pol foundation YMT ayurvedic medical college and hospital |
| Address |
3rd floor shalyatantra department Dr G D pol foundation YMT ayurvedic medical college and hospital PG Institute sector 4 kharghar Navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9322456999 |
| Fax |
|
| Email |
drsanjeevyadav22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata Lubal |
| Designation |
PG scholar |
| Affiliation |
Dr G D pol foundation YMT ayurvedic medical college and hospital |
| Address |
3rd floor shalyatantra department Dr G D pol foundation YMT ayurvedic medical college and hospital PG Institute sector 4 kharghar Navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8605610892 |
| Fax |
|
| Email |
namratalubal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr G D pol foundation YMT ayurvedic medical college and hospital PG Institute sector 4 kharghar Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Namrata Lubal |
| Address |
Dr G D pol foundation YMT ayurvedic medical college and hospital PG Institute sector 4 kharghar Navi Mumbai |
| 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 Namrata Lubal |
Dr G D pol foundation YMT ayurvedic medical college and hospital PG Institute |
405,505,4th floor and 5th floor Dr G D pol foundation YMT ayurvedic medical college and hospital PG Institute sector 4 kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA |
08605610892
namratalubal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N359||Urethral stricture, unspecified. Ayurveda Condition: MUTRAGHATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttarabastikarma, उतà¥à¤¤à¤°à¤¬à¤¸à¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushrut chikitsasthan 1/109, Procedure details: Route of admjnistration – through urethra
Formulation of drug- Ghrita
Time of adminstration – after micturition and defaecation
Dose -1/2 pal= 24ml
• Position – male – supine position
Female- lithotomy position
Duration of drug Administration- For 2 weeks with interval of 1 week
Diet- Normal diet
Follow up- 0,7th , 15th , 21st day
The procedure will be carried out in minor ot under all aseptic precautions.
Poorva karma-Patients were advised to pass their natural urges prior)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with history of stricture of urethra of mild to moderate
Patients of age group 18yrs to 70yrs |
|
| ExclusionCriteria |
| Details |
Patients of impacted calculus in the urethra and bladder neck
BPH nephrotic syndrome and neoplasm of lower urinary tract & congenital and severely symptomatic stricture urethra
Patients with uncontrolled DM and HTN Patients with HIV HBsAg STDs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
A.SUBJECTIVE CRITERIA
•Incomplete emptying
•frequency
•weak stream
•dribbling and straining
B.OBJECTIVE CRITERIA
1.Urine routine and microscopic
2.USG KUB
3. Urethrogram
|
21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| impact of Uttarbasti on the reduction of inflammation and scar tissue formation in the urethra, thereby preserving the structure and function of the urethra. |
Study will be done with 2 weeks with interval of 1 week
Follow up on -0th 7th 15th 21st day |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
01/04/2024 |
| 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="0"
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
|
AN ASSESSMENT OF EFFECT OF DHANYAK GOKSHUR GHRITA UTTARBASTI IN MUTRA MARG SANKOCH W.S.R TO URETHRAL STRICTURE-OPEN CLINICAL TRIAL
 
Sample size-37 Mode of administration- through urethra A. SUBJECTIVE CRITERIA
• Incomplete emptying
• frequency
• weak stream
• dribbling and straining
B. OBJECTIVE CRITERIA
1. Urine routine and microscopic
2. USG KUB
3. Urethrogram
|