| CTRI Number |
CTRI/2023/06/054495 [Registered on: 27/06/2023] Trial Registered Prospectively |
| Last Modified On: |
20/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Benign Prostatic Hyperplasia using Kushaadi Taila Matra Basti (in the form of enema) and Gokshura Kwath ( to be taken freshly prepared orally by the patient) |
|
Scientific Title of Study
|
A Clinical study of Kushaadi Taila Matra Basti and Gokshura Kwath in Vatashtheela (Benign Prostatic Hyperplasia) |
| 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 Ajay Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 249401 India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9412856414 |
| Fax |
|
| Email |
akg1409@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 249401 India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9412856414 |
| Fax |
|
| Email |
akg1409@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kajal Saini |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 249401 India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8171072006 |
| Fax |
|
| Email |
kajalsaini1227@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No-7, Rishikul Campus, Haridwar |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University, Railway Road, Harrawala, Dehradun |
| 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 Kajal Saini |
Rishikul Campus Haridwar |
OPD No-7, Department of Shalya Tantra, Rishikul Campus Haridwar, Uttarakhand Ayurved University Uttarakhand 249401 India
Hardwar
UTTARANCHAL |
8171072006
kajalsaini1227@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
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: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gokshura Kwath, Reference: Bhaishjya Ratnavali/35/4, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Gokshura Kwath 30 ml daily orally (morning time) | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Bhavprakash/37/59-62, Procedure details: Kushaadi Taila Matra Basti 30 ml once daily per rectum in left lateral lying position (morning time))
(1) Medicine Name: Kushaadi Taila, Reference: Bhavprakash/37/59-62, Route: Rectal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
1.Patients with classical signs and symptoms of
Vatashtheela
2.Age group 50 years or above 50 years |
|
| ExclusionCriteria |
| Details |
1.Age below 50 years
2.Patient with acute retention
3.Known malignant condition of Uro-genital system
4.Patient associated with other systemic disorder- Renal failure, Malignancy, immuno-compromised patients etc.
5.Patients not willing to undergo trial
6.Covid-19 non vaccinated patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in the symptoms like frequency of urination in day & night time urgency of urination & relief in signs such as enlargement of Prostate |
7th 14th 21st day & after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Expected improvement in the quality of life of patients by relief in the symptoms like decrease in the number of Micturition by patient during day & night, Urgency, as well as expected relief in reduction of size of Prostate gland of Prostate |
7th 14th 21st day & after treatment |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
28/06/2023 |
| 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="1"
Months="6"
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
|
BPH is a non- cancerous disease and it is a part of normal ageing process. The most widely acknowledged cause is an imbalance between androgen and estrogen. It cause symptoms like increased frequency of micturition in day as well as night time, urgency, etc. and signs like enlargement in Prostate size.
This study is a interventional, open level, single group trial, A Clinical study of Kushaadi Taila Matra Basti and Gokshura Kwath in Vatashtheela (Benign Prostatic Hyperplasia). The case will be selected randomly from OPD/IPD of Rishikul Campus Hospital, U.A.U, Haridwar (U.K.) India. The study will be intervened under one group with Kushaadi Taila (Matra Basti) and Gokshura Kwath (orally), duration of trial will be 21 days. Assessment criteria will be done on subjective and objective parameters. Subjective parameters on the basis of International prostate symptom score (IPSS) and objective parameters on residual urine volume and prostate size volume. |