| CTRI Number |
CTRI/2022/12/048483 [Registered on: 26/12/2022] Trial Registered Prospectively |
| Last Modified On: |
25/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A COMPARATIVE CLINICAL STUDY OF UTTARA BASTI AND URETHRAL DILATATION IN MOOTROTSANG (STRICTURE URETHRA) |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY OF JATYAADI TAIL UTTARA BASTI AND URETHRAL DILATATION IN MOOTROTSANG (STRICTURE URETHRA) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Sunil Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Gurukul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand |
| Address |
Shalya OPD, Gurukul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand
Vishnu Garden, near Lok Seva Ayog, Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9414255715 |
| Fax |
- |
| Email |
suniljivaidya@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sunil Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Gurukul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand |
| Address |
Shalya OPD, Gurukul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand
Vishu Garden, near Lok Seva Ayog, Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9414255715 |
| Fax |
- |
| Email |
suniljivaidya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvesh Kumar Dubey |
| Designation |
PhD Scholar |
| Affiliation |
Gurukul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand |
| Address |
Near Labour Chawk, Ramnagar, Ashok Marg, Roorkee, Uttarakhand
Roorkee Hospital, Ramnagar, near Labour Chawk, Roorkee, Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9548329018 |
| Fax |
- |
| Email |
Dr.sarvesh.dubey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gurukul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Gurukul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand |
| Address |
Shalya OPD, Gurukul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand |
| 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 SARVESH KUMAR DUBEY |
Gurukul Campus |
OPD No 7, Shalya Tantra OPD, Gurukul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand
Hardwar
UTTARANCHAL |
9548329018
-
Dr.sarvesh.dubey@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:N359||Urethral stricture, unspecified. Ayurveda Condition: MOOTROTSANG (URETHRAL STRICTURE), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Urethral dilatation | (Procedure Reference: , Procedure details: Intermittent urethral dilatation with metallic bougies will be done biweekly for 1 week, weekly for next 3 weeks and assessment will be done after procedure for 1 month. )
| | 2 | Comparator Arm | Procedure | - | Uttara basti and urethral dilatation | (Procedure Reference: , Procedure details: The procedure of Uttara Basti will be scheduled for 7 days and urethral dilatation with metallic bougie will be done biweekly for 1 week, weekly for next 3 weeks and assessment will be done after every dilatation for 1 month. The assessment will be done after completion of every sitting for 1 month.)
|
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Mild to moderate symptoms of urethral stricture.
2. Length of urethral stricture < 2cm.
3. Single urethral stricture.
4. Stage A (As per Devine Classification of stricture urethra on the basis of depth of the urethral stricture) |
|
| ExclusionCriteria |
| Details |
1. Impacted calculus in the urethra and bladder neck.
2. BPH, Nephrotic syndrome, ARF, CRF, Neoplasm of lower urinary tract, Ca Bladder.
3. HIV Reactive, HbsAg reactive.
Congenital and severely symptomatic stricture urethra.
4. Multiple strictures (> 1) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cured : More than 75% relief in the complaints of patient.
Marked Improvement : 50.1 - 75% relief in the complaints of patient.
Improvement : 25.1-50% relief in the complaints of patient.
Unchanged : Up to 25% relief in the complaints of the patients.
|
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| exacerbation in signs and symptoms |
exacerbation in signs and symptoms |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/12/2022 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Urethral stricture is a disease of Mootravaha Srotas in which there is narrowing of lumen of urethra causing obstructing symptoms. The stricture can develop anywhere along the length of male urethra and can be due to many etiologies. It is directly associated with quality of life of patients. As per Ayurvedic anatomy, disease related to genitourinary system falls under Mootravaha Srotas vyadhi. Acharya Sushruta has classified Mootraghata into 12 types.[i] Mootramarga Samkocha is not explained with separate title but the symptoms are similar to Mootrotsanga. Acharya Sushruta has explained Uttarbasti as treatment procedure of Mootrotsanga which is one of the types of Mootraghaat.[ii] Acharya Charaka has classified urinary disease like Mootra krichhra into 8 types. Total 60 patients of Mootrotsang w.s.r. stricture of urethra will be selected from the O.P.D./ I.P.D. of the attached Hospitals of Uttarakhand Ayurved University. The study will be conducted on randomly divided 2 groups that means 30 patients in each group on the basis of criteria of inclusion and exclusion with detailed clinical history and physical examination and other necessary investigations. It will be a clinical study with pre-test and post-test design wherein a minimum of 60 patients suffering from Mootrotsang will be selected according to the inclusion criteria irrespective of their occupation, caste or creed. The parameters of sign and symptoms will be analyzed statistically. Subjects will be administered with Jatyaadi tail Uttara Basti and Urethral dilatation Group A- 30 Patients will be given Jatyaadi tail Uttara Basti. Group B- 30 Patients will be given urethral dilatation.
1. [i] Sushruta, Sushruta Samhita, Ayurved Tatvasandipika Hindi Commentary, Uttar Tantra, Varanasi: Chaukhamba Sanskrita Santhan; 2002.Adhyaaya, 58, verse 3-4:p. 539 2. [ii] Sushruta, Sushruta Samhita, Ayurved Tatvasandipika Hindi Commentary, Uttar Tantra, Varanasi: Chaukhamba Sanskrita Santhan; 2002.Adhyaaya, 58, verse 27-28:p. 544As per Ayurvedic anatomy, disease related to genitourinary system falls under Mootravaha Srotas vyadhi. Acharya Sushruta has classified Mootraghata into 12 types.[i] Mootramarga Samkocha is not explained with separate title but the symptoms are similar to Mootrotsanga. Acharya Sushruta has explained Uttarbasti as treatment procedure of Mootrotsanga which is one of the types of Mootraghaat.[ii] Acharya Charaka has classified urinary disease like Mootra krichhra into 8 types.
1. [i] Sushruta, Sushruta Samhita, Ayurved Tatvasandipika Hindi Commentary, Uttar Tantra, Varanasi: Chaukhamba Sanskrita Santhan; 2002.Adhyaaya, 58, verse 3-4:p. 539 2. [ii] Sushruta, Sushruta Samhita, Ayurved Tatvasandipika Hindi Commentary, Uttar Tantra, Varanasi: Chaukhamba Sanskrita Santhan; 2002.Adhyaaya, 58, verse 27-28:p. 544 |