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A comparative clinical study to evaluate the effect of medicated alkali & placebo in Obesity induced diabetic patients with special reference to Benign prostate Hyperplasia

A COMPARATIVE SINGLE BLIND PLACEBO CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECT OF ERANDA PATRA KSHARA IN STHULA PRAMEHI W S R TO BPH - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054182
Enrollment
100
Registered
2023-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: E086- Diabetes mellitus due to underlying condition with other specified complications

Interventions

None listed

Sponsors

Rajiv Gandhi Education Societys Ayurvedic Medical College Hospital And Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients between the age group 55 to 75 years will be selected. 2) Patient with BMI between 28 kg /m2 to 39.9 kg/m2 will be included in this study. 3) Abdominal circumference over > 40 inches will be considering. 4) Patient with the history of DM less than 3 year will be included in the study. 5) Blood sugar with the range of FBS 110 - 170mg /dl 6) Patient with PSA between >4 μg/L to 7) Patients with Prostate volume (PV) >80 ml will be included 8) Prostate size >30 gms and 9) Post residual urine volume [PRUV] >50 ml will be included

Exclusion criteria

Exclusion criteria: 1) Patient associated with systemic disorders viz. CVD, Endocrine disorders affecting the clinical trial. 2) On long term medication that may interfere the study. 3) Obese patient suffering from Hemiplegia, associated with sever Hypertension and from other such diseases in which the patient cannot do his routine physical activities were excluded. 4) Any physical and systemic disability that may interfere the clinical trial. 5) BMI > 40 kg/m2 Obesity Class â??III 6) Blood sugar with the range of FBS more than 180 mg /dl were excluded 7) Patient with PSA >8 μg/L and Prostate Cancer will be excluded 8) Prostate size >60 gms

Design outcomes

Primary

MeasureTime frame
Prostatic enlargement by digital and Ultrasonographic methodsTimepoint: at baseline and on 60th day

Secondary

MeasureTime frame
BMI (kg/m2) FBS, PPBS, Lipid Profile Urine Flow & Initiation, Night frequency Urine incontinencyTimepoint: at baseline & on 60th day

Countries

India

Contacts

Public ContactDr Raghavendra Shettar

Parul Institute of Ayurved

drsangeetaj@gmail.com9964596479

Outcome results

None listed

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