Effect of Chandraprabha Vati along with Gokshuradi Guggulu in patients of Benign Prostatic Hyperplasia (BPH)

Phase 2

• Conditions: Health Condition 1: N40- Benign prostatic hyperplasia

• Registration Number: CTRI/2023/06/053971
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Goverment of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Prostate volume > 20 and = 50 gm by Transabdominal ultrasound

2. Newly diagnosed case of BPH or who have discontinued any other medication for BPH or related complaints for minimum three months prior to enrollment

3. Willing and able to give written informed consent and comply with study procedures

4. Willing and able to participate in the study for full three months.

Exclusion Criteria

1. PSA > 4 ng/ml

2. Previous prostatic surgery (including TURP, balloon dilatation, thermotherapy, and stent replacement) or other invasive procedures to treat BPH

3. Post-void residual volume >250mL (Transabdominal ultrasound)

4. history of Acute Urine Retention within three months before screening

5. History of confirmed malignancy or cancer of prostate or bladder or has an imminent need for surgery

6. Participants with uncontrolled Hypertension with or without medication. (BP= 160/100 mm of Hg)

7. Participants with uncontrolled Diabetes mellitus with or without medication (HbA1c > 8%).

8. Participants with concurrent serious cardiac dysfunction or Hepatic Dysfunction (defined as AST and/or ALT >two times of the standard upper limit) or Renal Dysfunction as serum creatinine level more than the upper limit of lab value, uncontrolled Pulmonary Dysfunction (Asthmatic and COPD patients) or any other concurrent severe disease.

9. Participants participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study

10. Participants who are taking Ayurvedic treatment/medicine for any disease condition for the last three months

11. Participants with impaired cognition, or with a history or diagnosis of psychiatric illness and neurological disorders, etc

12. Subjects who are already taking any other medication for treatment of BPH or any related complaints

13. Use of Any other condition that PI may think can jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Changes in Lower Urinary Tract Symptoms (LUTS) & quality of life in men with benign prostatic hyperplasia by International Prostate Symptom Score (IPSS) <br/ ><br>•Changes in prostate volume, post-void residual (PVR), Maximum flow rate, Mean flow rate <br/ ><br>Timepoint: 03 Months <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
•Changes in laboratory parameter viz. CBC, LFT, RFT & Lipid profileTimepoint: 03 Months