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CTRI Number  CTRI/2018/01/011287 [Registered on: 12/01/2018] Trial Registered Prospectively
Last Modified On: 11/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   The study of Ayurvedic Classical formulations in Benign Prostatic Hyperplasia. 
Scientific Title of Study   Clinical evaluation of Triphala Guggulu with Varunadi kvatha in the management of vatashthila(Benign Prostatic hyperplasia). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tejas Navinchandra Gandhi 
Designation  PG scholar, Kayachikitsa department. 
Affiliation  J. S. Ayurved College, Nadiad. 
Address  J. S. Ayurved College,college road, Nadiad-387001.

Kheda
GUJARAT
387001
India 
Phone  9033446799  
Fax    
Email  tngandhi77@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manish V Patel 
Designation  PhD(Ayu). Professor-Kayachikitsa department  
Affiliation  J S Ayurved College Nadiad 
Address  J. S. Ayurved College,college road, Nadiad-387001.

Kheda
GUJARAT
387001
India 
Phone  9979589865  
Fax    
Email  manishayu97@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Tejas Navinchandra Gandhi 
Designation  PG scholar, Kayachikitsa department. 
Affiliation  J S Ayurved College Nadiad 
Address  J. S. Ayurved College,college road, Nadiad-387001.

Kheda
GUJARAT
387001
India 
Phone  9033446799  
Fax    
Email  tngandhi77@gmail.com  
 
Source of Monetary or Material Support  
J. S. Ayurved College and P. D. Patel Ayurved Hospital, Nadiad. 
 
Primary Sponsor  
Name  J S Ayurved college Nadiad  
Address  J.S. Ayurved college, college road, Nadiad. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Tejas Navinchandra Gandhi  P D Patel Ayurveda Hospital  Kayachikitsa and Panchkarma department.
Kheda
GUJARAT 		 9033446799

tngandhi77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients of Benign Prostatic Hyperplasia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayurvedic classical herbal formulation  1. Triphala Guggulu 3 tab(each tab 300mg) thrice a day after meal orally with warm water 2. Varunadi kvatha(decoction) 40 ml twice a day empty stomach orally 
Comparator Agent  Not Applcable  Not Applicable 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  1. Patient willing to fill the informed consent form.
2. Patient with confirmed diagnosis of BPH.
 
 
ExclusionCriteria 
Details  1. Patient of BPH having disease or/and under any medication that affects study, study drug and its result or prognosis will be excluded i.e. established hypertension, Diabetes mellitus, Renal failure, Hepatic failure, Cardiac failure, HIV positive cases
2. Patient with malignancy.
3. Case of Medical emergency or immediate surgical intervention.
4. Cases with complete urethral stricture.
5. Severe Hematuria.
6. Acute retention of urine.
7. Developmental defects of Prostate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
effect of ayurvedic management in the patient of Benign prostatic hyperplasia  grade score of sign and symptoms along with usg investigation before treatment and after treatment of 28 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Not Applicable 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   15/01/2018 
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   Not applicable because of thesis work will yet to be submit 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Clinical Evaluation of Triphala Guggulu with Varunadi kvatha in the management of vatasthila (Benign Prostatic Hyperplasia) is the main object of the study. Patient will be selected from P D Patel Ayurved Hospital, Nadiad after the confirmation of the patient of the BPH with the help of classical sign and symptoms. They will be treated with following therapy.
1. Triphala Guggulu(compound of Triphala+Pippali+Guggulu) 3 tab (each tab 300mg) thrice in a day after meal with warm water orally.
2 Varunadi Kvatha(compound of Varuna+Bilvamoola+Apamarga+chitrakamoola+Agnimantha+sigru+kantakari+kalamegha+karanja+shatavari) 40ml twice in a day empty stomach oraly.
Total duration of treatment for the main assessment period will be of 4 weeks . Assessment will be done with the help of International Prostate Symptom Score(IPSS) and by observing improvement in prostate size and residual urine volume with the help of USG before and after treatment . The study will be analysed with the help of student ’t’ test
 
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