CTRI

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CTRI Number

CTRI/2023/06/053675 [Registered on: 08/06/2023] Trial Registered Prospectively

Last Modified On:

07/06/2023

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Process of Care Changes

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Clinical evaluation of Hyprost capsules in the management of Benign Prostatic Hyperplasia

Scientific Title of Study

Clinical evaluation of Hyprost capsules in the management of Benign Prostatic Hyperplasia with or without LUTS- An open labeled, randomized, clinical trial.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr TS Dudhamal
Designation	MS-Ayu, PhD, Associate Professor and Incharge HOD
Affiliation	Dept. of Shalya Tantra, ITRA, Jamnagar
Address	Dept. of Shalya Tantra, ITRA, Jamnagar Opp. B-Division Police Station Gurudwara Road, Jamnagar Gulabkurba ayurved college jamnagar Jamnagar GUJARAT 361008 India
Phone	9428671939
Fax
Email	dudhamal@itra.edu.in

Details of Contact Person
Scientific Query

Name	Dr TS Dudhamal
Designation	Associate Professor and Incharge HOD
Affiliation	Department of Shalya Tantra, ITRA, Jamnagar
Address	Opposite B Division Police Station Gurudwara Road, Jamnagar Gulabkurba ayurved college panchkarma bhawan Jamnagar GUJARAT 361008 India
Phone	9428671939
Fax
Email	dudhamal@itra.edu.in

Details of Contact Person
Public Query

Name	Dr Tukaram S Dudhamal
Designation	Associate Professor and Incharge HOD
Affiliation	Department of Shalya Tantra, ITRA, Jamnagar
Address	Opposite B Division Police Station Gurudwara Road, Jamnagar Panchkarma Bhawan UG campus Jamnagar Jamnagar GUJARAT 361008 India
Phone	9428671939
Fax
Email	dudhamal@itra.edu.in

Source of Monetary or Material Support

Zoetic ayurvedics pvt limited

Primary Sponsor

Name	Zoetic Ayurevedics Pvt. Ltd. Ahmedabad, Gujarat
Address	8thFloorâ€theChmabersâ€OppNewgurudwara, Sarkhej- Gandhinagar Highway, Ahmedabad-380054
Type of Sponsor	Pharmaceutical industry-Indian

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
Dr TS Dudhamal	UG hospital, gulab kunwarba ayurved hospital ITRA	OPD no. 3 SHALYA tantra first floor, UG hospital ITRA Jamnagar GUJARAT	9428671939 dudhamal@itra.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee Institute of Teaching and Research in Ayurveda	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:N40\|\|Benign prostatic hyperplasia. Ayurveda Condition: Mutraghatah,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Hyprost, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 60 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -not applicable
2	Comparator Arm	Drug	Other than Classical		(1) Medicine Name: Tamsulosin Hydrochloride, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 0.2(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	40.00 Year(s)
Age To	70.00 Year(s)
Gender	Male
Details	Patients having signs and symptoms of BPH. Grade 1 to Grade 3 BPH Weight of prostate gland-30-85 g Patient with Sr. PSA value <4ng/ml Uroflomerty with peak flow rate between 10-15ml /sec Patients with IPSS Score 0-35 (complete range taken)

ExclusionCriteria

Details

Age below 40 years.
Patients of malignancy, congenital deformities of urogenital tract or any abdomino- pelvic pathology other than BPH.
Patients of uncontrolled Diabetes mellitus (FBS: >140mg/dl, PPBS:>180mg/dl)
Patient of Uncontrolled Hypertension ICD-10(BP >140/90 mm of Hg)
Known case of cardiac diseases like IHD, MI, CAD.
Congenital deformities of urogenital tract or any abdomino- pelvic pathology other than BPH.
Systemic diseases like Tuberculosis, Paralysis, Parkinsonism history of MI, etc. will be excluded.
Patients with history of catherization, retention, hydronephrosis or impaired kidney function will be excluded.
Patients with USG findings of PVRU > 100ml
Patients with evidence of Prostatic malignancy

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Relieve in Sign and symptoms of LUTS	After completion of 60 days intervention

Secondary Outcome

Outcome	TimePoints
Reduce size of prostate	8 weeks

Target Sample Size

Total Sample Size="150"
Sample Size from India="150"
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 4

Date of First Enrollment (India)

14/07/2023

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="0"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Not applicable

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary

Benign prostate hyperplasia is a common clinical entity in after 50 years of male patients. Irritative and obstructive symptoms with progressive age make condition more worse. In proposed clinical trial the outcome assesment will be assess according to relieve in obstructive as well as irritative symptoms.