| CTRI Number |
CTRI/2024/07/071543 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study To Evaluate The Efficacy of Ayurvedic Drug In The Treatment Of BPH (Benign Prostate Hyperplasia) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Evaluate The Efficacy of Devdarvyadi Churna In The Management Of Vatashthila w.s.r. To BPH (Benign Prostate 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 |
Rushda Nazir Ahmed Karjikar |
| Designation |
PG Scholar MS Shalyatantra |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8087837415 |
| Fax |
|
| Email |
rushdakarjikar97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Borase |
| Designation |
HOD & Professor MS Shalyatantra |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8329008455 |
| Fax |
|
| Email |
dryogeshborase@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rushda Nazir Ahmed Karjikar |
| Designation |
PG Scholar MS Shalyatantra |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
2nd floor, Shalyatantra department, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8087837415 |
| Fax |
|
| Email |
rushdakarjikar97@gmail.com |
|
|
Source of Monetary or Material Support
|
| MES Ayurved Mahavidyalaya & attached Parshuram Hospital & Research Center, Ghanekhunt Lote, Khed, Ratnagiri, Maharashtra, India-415722. |
|
|
Primary Sponsor
|
| Name |
Dr Rushda Nazir Ahmed Karjikar |
| Address |
MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri, Maharashtra, India-415722. |
| 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 |
| Dr Rushda Nazir Ahmed Karjikar |
Parshuram Hospital & Research Center |
Shalyatantra OPD, Ghanekhunt Lote, Khed
Ratnagiri
MAHARASHTRA |
8087837415
rushdakarjikar97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MES Ayurved Mahavidyalaya Ethics Committee |
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 | Drug | Classical | | (1) Medicine Name: Devdarvyadi churna, Reference: Va.Bh./Chi.A-11/36, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Tab Himplasia, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1) Patients with mild and moderate symptoms as per American Urological Association score (IPSS) given for BPH.
2) Patients having samanya lakshana(Symptoms) of Vatashthila(BPH).
3) Patients will be included irrespective of their caste, religion, economic status, occupation.
4) Patients only those who are ready to give written consent will be selected.
|
|
| ExclusionCriteria |
| Details |
1) Patients having – Acute urinary retention, Stricture of Urethra, Carcinoma of Prostate, Bladder polyp, Hydronephrosis, Congenital contracture of Bladder neck, Carcinoma of Urinary tract, Neurogenic bladder.
2) Patients with severe systemic diseases like- Renal failure, Cardiovascular disorders, uncontrolled diabetes mellitus and hypertension, Tuberculosis, HIV- Immuno compromised patients.
3) Patients those who are not ready to give written consent. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Devdarvyadi Churna in the management of Vatashthila w.s.r to BPH |
90 days study with
Follow-up on- 15th ,30th ,90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study the etiopathogenesis of Vatashthila w.s.r to BPH
2)To study the Literature of Devdarvyadi Churna |
90 days study with
Follow-up on- 15th ,30th ,90th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
09/08/2024 |
| 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
|
Title:- A Randomized Controlled Clinical Trial To Evaluate The
Efficacy Of Devdarvyadi Churna In The Management Of Vatashthila w.s.r. To BPH (Benign Prostate
Hyperplasia).
Null Hypothesis:- Devdarvyadi Churna
is not
significantly effective in Vatashthila (BPH).
Alternate Hypothesis:- Devdarvyadi Churna is significantly effective in Vatashthila
(BPH).
Study design:- Simple Randomized Controlled Clinical Trial. 1) Age: Patients age between 45 to 70 years. 2) Patients with mild and moderate symptoms as per American Urological Association score (IPSS) given for BPH. 3) Patients having samanya lakshana(Symptoms) of Vatashthila(BPH). 4) Patients will be included irrespective of their caste, religion, economic status, occupation. 5) Patients only those who are ready to give written consent will be selected.
Exclusive Criteria:- 1) Age: Patients age less than 45 years and more than 70 years. 2) Patients having – Acute urinary retention, Stricture of Urethra, Carcinoma of Prostate, Bladder polyp, Hydronephrosis, Congenital contracture of Bladder neck, Carcinoma of Urinary tract, Neurogenic bladder. 3) Patients with severe systemic diseases like- Renal failure, Cardiovascular disorders, uncontrolled diabeties mellitus and hypertension, Tuberculosis, HIV- Immuno compromised patients. 4) Patients those who are not ready to give written consent.
Sample size:- Total 60 (30 for each group).
Patients coming in OPD and IPD of Shalyatantra department
of our hospital with complaints of Vatashtila(BPH). Simple randomized sampling ( Lottery Method).
Group A:- Devdarvyadi Churna. Group B:- Tab. Himplasia. Total duration of drug administration is 90 days. The mode of drug administration will be by oral route.
Followup:- Followup will be done on 15th,30th & 90th day.
Result:- Result will be drawn as per assessment criteria & statistical analysis.
|