| CTRI Number |
CTRI/2024/10/074700 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Kushmanda Taila Uttar Basti in the management of Mutraghata (BPH). |
|
Scientific Title of Study
|
Effect of Kushmanda Taila Uttar Basti in the management of Mutraghata w.s.r. to BPH. |
| 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 Mohit Bhati |
| Designation |
MS PG Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research center Shobhit University, Gangoh. |
| Address |
OPD no 3 Department of Shalya Tantra Kunwar Shekhar Vijendra Ayurved Medical College and Research center Shobhit University, Gangoh, Saharanpur
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
8923116226 |
| Fax |
|
| Email |
bmohit687@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjit Singh Manhas |
| Designation |
MS Ayurveda Professor department of Shalya Tantra |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Center |
| Address |
OPD no 3 Department of Shalya Tantra Kunwar Shekhar Vijendra Ayurved Medical College and Research center Shobhit University, Gangoh
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9461940996 |
| Fax |
|
| Email |
ranjit198330@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjit Singh Manhas |
| Designation |
MS Ayurveda Professor department of Shalya Tantra |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Center |
| Address |
OPD no 3 Department of Shalya Tantra Kunwar Shekhar Vijendra Ayurved Medical College and Research center Shobhit University, Gangoh
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9461940996 |
| Fax |
|
| Email |
ranjit198330@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kunwar Shekhar Vijendra Ayurved Medical College and Research center,Gangoh, Saharanpur, Uttar Pradesh,247341 |
|
|
Primary Sponsor
|
| Name |
Dr Mohit Bhati |
| Address |
OPD no 3 Department of Shalya Tantra Kunwar Shekhar Vijendra Ayurved Medical College and Research centre Shobhit University, Gangoh, Uttar Pradesh,247341 |
| 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 Mohit Bhati |
Kunwar Shekhar Vijendra Ayurved Medical College and Research center |
OPD no 3 Department of Shalya Tantra Kunwar Shekhar Vijendra Ayurved Medical College and Research centre Shobhit University, Gangoh, Uttar Pradesh,247341
Saharanpur
UTTAR PRADESH |
8923116226
bmohit687@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kunwar Shekhar Vijendra Ayurved Medical College and Research Center, Gangoh, Saharanpur, Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N400||Benign prostatic hyperplasia without lower urinary tract symptoms. Ayurveda Condition: MUTRAGHATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Uttar basti | (Procedure Reference: Bhav prakash 36/35, Procedure details: Uttar basti of Kushmanda tail will be given 3 consecutive days with a gap of 3 days.)
(1) Medicine Name: Kushmanda tail, Reference: Raj nighantu 7/161, Route: Urethral, Dosage Form: Taila, Dose: 24(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Diagnosed patients of Grade 1 and Grade 2 BPH.
Patients aged in between 40 and 70 years. |
|
| ExclusionCriteria |
| Details |
Patients not having normal PSA value.
Patients suffering from acute retention of urine,severe UTI, urethral stricture and bladder and ureteric calculi.
Patients having other systemic diseases.
Subjects under medications.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the size of prostate. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relieve in urine obstruction. |
After analysing all the parameters the result will be assessed on the basis of symptomatic relief and improvement.
Partially improvement after 7 days- patients get 40-60 percent relief from sign and symptoms.
Improvement after 14 days- patient get 60-80 percent relief from sign and symptoms.
Cured after 21 days- Patient get 80-100 percent relief from sign and symptoms. |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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="0"
Months="10"
Days="10" |
|
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
|
Mutraghata is made up of two words i.e. Mutra (urine) and Aghata means obstruction of urinary passage. Hence vayu is responsible for this obstruction so the basic line of treatment is to reduce aggravation of vayu and basti is called ardhachikitsa of vatarogas. So I have selected Uttar basti procedure with Kushmanda Beej Taila which reduces obstruction of urine and makes the flow of urine easy . Therefore I have selected this trial, there will be 30 patients aged between 40 to 70 years,the patients should be selected on the basis of inclusion and exclusion criteria. The trial will be of 21 days, during trial follow up will be 3 consecutive days with the gap of 3 days. After trial follow up will be done after 15th,30th,45th days after cessation of procedure. |