| CTRI Number |
CTRI/2023/06/054488 [Registered on: 27/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of dashamool shilajit vati on prostate enlargement |
|
Scientific Title of Study
|
A Randomised controlled clinical study to evaluate the efficacy of dashamool shilajit vati in the management of vatashtheela with special refernce to benign prostate hyperplasia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devata Panchakshari |
| Designation |
PhD Scholar |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwadi, Panchavati Nashik |
| Address |
OPD no 6 Shalyatantra OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
9422308136 |
| Fax |
|
| Email |
drdevata@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Sonambekar |
| Designation |
Guide ,HOD ,Principal |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya |
| Address |
OPD no 6 Shalyatantra OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822624890 |
| Fax |
|
| Email |
sonambekar.chinmay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinay Sonambekar |
| Designation |
Guide ,HOD ,Principal |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya |
| Address |
OPD no 6 Shalyatantra OPD
Nanded
MAHARASHTRA
422003
India |
| Phone |
9822624890 |
| Fax |
|
| Email |
sonambekar.chinmay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
|
|
Primary Sponsor
|
| Name |
Ayurved seva sangh Ayurved Mahavidyalaya |
| Address |
Ganeshwadi, Panchvati,Nashik Dist Nashik -422003 |
| Type of Sponsor |
Other [State Government aided institution] |
|
|
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 Devata Panchakshari |
Arogyashala Rugnalaya |
OPD No 6 Shalyatantra OPD
Nashik
MAHARASHTRA |
9422308136
drdevata@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee ASS Ayurved Mahavidyalaya Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N40||Benign prostatic hyperplasia. Ayurveda Condition: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashamool shilajit vati, Reference: Yogratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tamsulosin Hydrochloride | Tamsulosin Hydrochloride 400 mg 1 HS for 3 months |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
Patients with clinical features of BPH like Increases frequency, Weak urinary flow, Urgency of micturation,Nocturia,Straining during micturation and feeling of incomplete emptying of bladder,having post voiding residual volume upto 200 ml,patients willing to participate in clinical trial |
|
| ExclusionCriteria |
| Details |
diagnosed case of malignancy of prostate, urethral stricture, active UTI, Patients with uncontrolled DM, TB, Malignancy and HBV
Patients with imapaired renal function
other systemic disorders which can interfere with course of the treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in prostate size
Change in urine Frequency, Urgency of micturition, Nocturia, Straining during micturition |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in prostate size
Reduction in post voidal residual urine volume |
3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2023 |
| 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
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
BPH is one of the most common senile disese in males.Almost each and every male is affected by this disease hampering the quality of life.Hence the whole world is looking for alternative safe and sure treatment.In Ayurvedic samhitas,BPH is clinically similar to Vatashtheela and here its management is discussed.We have decided to search remedial solution for this burning problem which should be safer ,cost effective and easily available.We have taken 2 groups-Group A which is a study group of 45 patients which will be treated with Dashamool shilajit vati 250 mg 2 bid for 3 months.Group B whichis a control group of 45 patients treated with Tab Tamsulosin Hydrochloride 400 mg 1 at HS for 3 moths.Assessment criteria is as per IPSS -International Prostate Symptoms Scoring.Analysis of data will be done by scientific methods with the help of statistician.All clinical findings are recorded in case record forms CRF. |