| CTRI Number |
CTRI/2025/01/079491 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Unani formulation in Lower Urinary Tract Symptoms |
|
Scientific Title of Study
|
Efficacy of Kabab Chini in Lower Urinary Tract Symptoms associated with Benign Prostatic Hyperplasia: A randomized, double-blind, placebo-controlled clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchir Kumar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Moalajat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru
Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9457061431 |
| Fax |
|
| Email |
hkm.ruchir016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Riyazuddin |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Moalajat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru
Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
8010392768 |
| Fax |
|
| Email |
shaikh.riyaz368@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Riyazuddin |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Moalajat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru
Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
8010392768 |
| Fax |
|
| Email |
shaikh.riyaz368@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Kottigepalya Magadi Main Road, Bangaluru, Karnataka 560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
Department of Moalajat, National Institute of Unani Medicine, Kottigepalya Magadi Main Road, Bengaluru-560091 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ruchir Kumar |
National Institute of Unani Medicine and Hospital |
OPD NO. 1, 2 & 7 ,Department of Moalajat, Kottigepalya Magadi Main Road Bengaluru Karnataka 560091
Bangalore
KARNATAKA |
9457061431
hkm.ruchir016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee(IEC) for Biomedical Research |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kabab Chini (Piper cubeba Linn.) |
Kabab Chini will be powdered finely and filled in 750mg capsules Each patient will be given 3 gm of the test drug per day by giving 2 capsules of 750 mg orally with water twice a day after meals |
| Comparator Agent |
Placebo |
Wheat flour will be given 3 gm per day by giving 2 capsules of 750 mg orally with water twice a day after meals same as test group |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Male patients of age more than 40 and less than 80 years
Patients with a history of LUTS (Urgency, Frequency, Nocturia, Incontinence, Weak stream, Straining, Dribbling of urine) attributable to BPH
Mild (1 to 7) and Moderate (8 to 19) cases, according to IPSS
PVR less than 150 ml and weight of prostate more than 20 gm as seen in USG
BPH Grade I, II and III
Patients willing to give their written informed consent and are able to do follow-up |
|
| ExclusionCriteria |
| Details |
Subjects having urinary retention (PVR more than 150 ml), hematuria, urinary tract infection, renal and hepatic impairment, urinary tract calculi, and congenital deformities of the urogenital tract or any abdominopelvic pathology other than BPH
Known cases of bladder or urethral strictures, neurologic bladder dysfunction, and prostate and bladder cancer
Subjects with a history of use of drugs with antiandrogenic properties and prostate surgery or other invasive procedure
Subjects with uncontrolled hypertension (more than 140/90 mmHg), diabetes mellitus
(RBS more than 200 mg/dl), and other systemic illness
Subject with Serum PSA more than 4ng/ml |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in IPSS Score |
0th, 15th, 30th and 45th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prostate size reduction as visualized in USG
Reduction in PVR (Pre and Post)
Improvement in Activities of Daily Living (ADL) assessed by BPH-specific QoL scale |
0th and 45th days |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
24/03/2025 |
| 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
|
Purpose: To Evaluate the Efficacy of Kabab Chini in Lower Urinary Tract Symptoms associated with Benign Prostatic Hyperplasia Design: A randomized double-blind placebo controlled clinical trial Intervention: A test group will be given Kabab chini 3gm in two divided doses, and a Placebo (Wheat flour) will be given in the same as of test group. Main Outcome Measures: The primary outcomes: Improvement in IPSS Score Secondary outcomes: Prostate size reduction as visualized in USG, Reduction in PVR (Pre and Post), Improvement in Activities of Daily Living (ADL) assessed by BPH- specific QoL scale |