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Efficacy of Unani formulation in Lower Urinary Tract Symptoms

Efficacy of Kabab Chini in Lower Urinary Tract Symptoms associated with Benign Prostatic Hyperplasia: A randomized, double-blind, placebo-controlled clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079491
Enrollment
42
Registered
2025-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Interventions

Intervention1: 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 m

Sponsors

National Institute of Unani Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Improvement in IPSS ScoreTimepoint: 0th, 15th, 30th and 45th days

Secondary

MeasureTime frame
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 scaleTimepoint: 0th and 45th days

Countries

India

Contacts

Public ContactDr Mohd Riyazuddin

National Institute of Unani Medicine

shaikh.riyaz368@gmail.com8010392768

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026