| CTRI Number |
CTRI/2021/03/032042 [Registered on: 16/03/2021] Trial Registered Prospectively |
| Last Modified On: |
11/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Prolapse of Rectum OR Gudabhransa and its Ayurvedic treatment |
|
Scientific Title of Study
|
Clinical and scientific evaluation of Gudabhransa (Prolaps of Rectum) and its management |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nagesh Kumar Yadav |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalya Tantra
Faculty of Ayurveda
IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9532682872 |
| Fax |
|
| Email |
nageshbhu2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfLakshman Singh |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalya Tantra
Faculty of Ayurveda
IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415687065 |
| Fax |
|
| Email |
drlsingh@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Nagesh Kumar Yadav |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalya Tantra
Faculty of Ayurveda
IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9532682872 |
| Fax |
|
| Email |
nageshbhu2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| Banaras Hindu University, Varanasi U.P. INDIA |
|
|
Primary Sponsor
|
| Name |
DrNagesh Kumar Yadav |
| Address |
Vill-Utirai,Post Baderi,Distric Jaunpur,U.P.PIN 222127 |
| Type of Sponsor |
Other [Phd Student] |
|
|
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 |
| DrNagesh Kumar Yadav |
Shalya OPD |
Department of Shalya Tantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH |
9532682872
nageshbhu2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee I.M.S.B.H.U |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K623||Rectal prolapse. Ayurveda Condition: guda bramsha, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ayurvedic oral drug therapy |
Changeri ghrita 6gm BD |
| Intervention |
Ayurvedic oral formulation along with basti therapy |
Changeri ghrita 6gm BD and Basti therapy with Narayan tail 20 ml per pectal OD for 21 days |
| Intervention |
modified thiersch operation |
modified thiersch operation or EACKS |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Partial prolapse of rectum
Mucosal Prolapse
patients not willing for major surgery |
|
| ExclusionCriteria |
| Details |
Prolapse haemorrhoids
Carcinoma of rectum
Complete rectal prolapse
Cystocoel
Rectocoel
Colitis
Uncontrolled diabetic mellitus
Immuno-compromised patients
Sentinel Tag
Haemorrhoid
HIV/HBsAg positive subjects
Patient with any systemic infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wexner Incontinence score |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ANAL TONE BY PER RECTAL DIGITAL EXAMINATION |
1 month |
| ANAL TONE BY anal manometry |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/04/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized trial done in India for Clinical and scientific evaluation of Gudabhransa (Prolapse of Rectum) and its management through Ayurvedic oral drug therapy, Basti therapy and surgical procedure, modified thiersch EACKS method. The primary outcome measures the Wexner incontinence score at 3 months.
|