| CTRI Number |
CTRI/2022/01/039716 [Registered on: 25/01/2022] Trial Registered Prospectively |
| Last Modified On: |
20/01/2022 |
| 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 Devdarvyadi Choorna in Prostate enlargement |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Study to Evaluate The Efficacy Of Devdarvyadi Choorna in Vatashthila With Special Reference 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 |
SAROJ KUMAR MUKHIYA |
| Designation |
PG SCHOLAR |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
| Address |
OPD no 6 Shalyatantra OPD
Ganeshwadi Panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
8449503173 |
| Fax |
|
| Email |
sarojmukhiya1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANTOSH PATHAK |
| Designation |
ASST. PROFESSOR |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
| Address |
OPD no 6 Shalyatantra OPD
Ganeshwadi Panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
7767939759 |
| Fax |
|
| Email |
drsantoshsp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANTOSH PATHAK |
| Designation |
ASST. PROFESSOR |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
| Address |
OPD no 6 Shalyatantra OPD
Ganeshwadi Panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
7767939759 |
| Fax |
|
| Email |
drsantoshsp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik. Ganeshwadi Panchavati Nashik 422003 |
|
|
Primary Sponsor
|
| Name |
Saroj Kumar Mukhiya |
| Address |
Ayurved Mahavidyalaya Nashik. Ganeshwadi Panchavati Nashik |
| 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 |
| Saroj Kumar Mukhiya |
Arogyashala Rugnalaya Nashik |
OPD no 6, shalyatantra OPD, Ganeshwadi Panchavati Nashik
Nashik
MAHARASHTRA |
8449503173
sarojmukhiya1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
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: Devdarvyadi Choorna, Reference: Ashtan Hridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Tamsulosin Hydrochloride | 0.4 mg OD Bed Time with Lukewarm water For 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
Patient with clinical features of BPH like
Reduced urinary flow
Hesistancy
Urgency of micturition
Nocturia
Increased frequency of micturition.
Patiens having post voiding residual volume from 50ml to 200ml.
Patients having International Prostate Symptom score(IPSS) Mild to moderate (IPSS<19)
Patient willing to participate in clinical study. |
|
| ExclusionCriteria |
| Details |
Diagnosed case of malignancy of prostate.
Diagnosed case of urethral stricture.
Active Urinary tract infection.
Patients with uncontrolled Diabetes Mellitus,T.B.,Malignancy,HBV.
Patients with impaired renal functions.
Other systemic disorders which can interfere with the course of treatment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the size of prostate
Decrease in the severity in sign and symptoms of BPH |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in sign and symptoms |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/02/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diagnosed BPH(Benign Prostate Hyperplasia) will be treated with 2 groups,Group A- Trial Group Drug- Devdarvyadi Choorna 5g twice a day Koshna jal for 30 days and Group B- Controlled group Drug- Tab Tamsulosin Hydrochloride 0.4mg at bed time(night) daily with lukewarm water for 30 days.30 patients will be taken in each group.Assessment criteria for study will be the patients fulfilling the diagnostic criteria and sign and symptoms of Vatashthilla with special reference to BPH,such as those patients willing to participate into the study,male patients of age between 50-75yrs.This disease is characterized by both obstructive symptoms like dribbling MicturItion, hesistancy,weak flow of urine stream and irritative symptoms like increase frequency of micturition,nocturnal incontinence and urgency of Micturation. These symptoms causes disturbances in work sleep and concentration and ultimately reduce the patients quality of life.Devdarvyadi Choorna is drug of choice for Vatashthila which contain all the necessary ingredients that are useful to breakdown pathophysiology of Vatashthila by their rasa and virya, vipak properties. Ayurveda Samhita gives us the opportunity to treat the Vatashthila.
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