| CTRI Number |
CTRI/2023/09/058014 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
22/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of matra basti of Varun taila and prostogrit in vatastheela(BPH) |
|
Scientific Title of Study
|
Clinical Evaluation of Matra Basti of Varun Taila and Prostogrit in Vatastheela (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 |
Sonal Bhatt |
| Designation |
PG Scholar |
| Affiliation |
Patanjali bhartiya ayurvigyana evam anusandhan sansthan haridwar |
| Address |
PG Department Of Shalya Tantra Patanjali Ayurveda Hospital
Haridwar
UTTARANCHAL
249405
India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8755918327 |
| Fax |
|
| Email |
drsonalbhatt1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Gupta |
| Designation |
Professor and HOD |
| Affiliation |
Patanjali bhartiya ayurvigyana evam anusandhan sansthan haridwar |
| Address |
Opd no. 15, shalya tantra department,Patanjali Bhartiya Ayurvigyan
Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9419135050 |
| Fax |
|
| Email |
chintu.925@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonal Bhatt |
| Designation |
PG Scholar |
| Affiliation |
Patanjali bhartiya ayurvigyana evam anusandhan sansthan haridwar |
| Address |
PG Department Of Shalya Tantra Patanjali Ayurveda Hospital
Hardwar
UTTARANCHAL
249405
India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8755918327 |
| Fax |
|
| Email |
drsonalbhatt1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali bhartiya ayurvigyana evam anusandhan sansthan haridwar |
|
|
Primary Sponsor
|
| Name |
Patanjali bhartiya ayurvigyana evam anusandhan sansthan haridwar |
| Address |
Patanjali bhartiya ayurvigyana evam anusandhan sansthan haridwar, Uttrakhand 49405 |
| Type of Sponsor |
Private 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 Sonal Bhatt |
Patanjali bhartiya ayurvigyana evam anusandhan sansthan haridwar Uttrakhand |
Opd no 15 dept of
shalya tantra , Patanjali
ayurvedic college and
hospital, haridwar
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL |
08755918327
drsonalbhatt1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan ,Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N401||Benign prostatic hyperplasia withlower urinary tract symptoms. Ayurveda Condition: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charak siddhi sthan 9/39, Procedure details: The procedure of administration of Basti in general can be divided into three stages, as
follows:
Purva Karma;- The patients will be instructed to come after a light diet (neither too Snigdha
nor too Ruksha , and not more than three-fourth of their usual diet).They will also advised to
come after elimination of stools and urine. The patients will mainly subjected to local
Abhyanga and Mridu Swedana prior to the administration of Matra Basti.
Pradhana Karma; - After Purva Karma , the patien)
(1) Medicine Name: Varun taila , Reference: Bhav prakash chikitsa sthan 37/58, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Prostogrit , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Diagnosed cases of BPH along with lower urinary tract symptoms.
Grade 1 and 2 Prostate enlargement.
Controlled Hypertension and Diabetes Mellitus |
|
| ExclusionCriteria |
| Details |
1. Serology positive
2. Stricture Urethra
3. Prostate carcinoma
4. Idiopathic bladder neck obstruction
5. Chronic Renal failure
6. Prostate calculi
7. Neurogenic bladder
8. K/C/O Cardiac disease |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be made on the basis of subjective and objective criteria
Serum PSA (Prostate Specific Antigen) test.
Urine Examination. (Routine/Microscopic)
Ultra-Sonography (USG) of abdomen and pelvis (pre and post void) |
0 , 13 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment will be made on the basis of subjective criteria
Incomplete emptying
Urgency
Straining
Weak stream
Nocturia
Frequency
|
0, 13 week |
|
|
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 2 |
|
Date of First Enrollment (India)
|
30/09/2023 |
| 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="4"
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
|
In this trail , we are selecting the patients of vatastheela (BPH) in which we will do the
intervention with Varun Taila Matra Basti procedure and Prostogrit tab orally 2 tab BD (500 mg each) till the prostate size decrease . Assessment will be done on
the basis of subjective and objective parameters. Subjective parameters includes incomplete emptying, frequency, urgency,nocturia,weak flow , straining and objectives parameters include prostate size volume |