Study to check the efficacy of Uttar Basti (administration of oil through urethra) and oral medicines in the management of Prostate Enlargement

Phase 2/3

Active, not recruiting

• Conditions: Benign prostatic hyperplasia withlower urinary tract symptoms. Ayurveda Condition: MUTRAGHATAH,

• Registration Number: CTRI/2022/02/039994
• Lead Sponsor: All India Institute of Ayurveda

Brief Summary

**Background:** BPH is a common condition that affects most of the adults as they grow older, and it greatly affects the quality of life. Modern treatment methods include oral treatments such as 5α-reductase inhibitors, α1 Adrenergic Antagonists (α1-Blockers), Muscarinic Receptor Antagonists (MRAs) which are known to have potential side effects. Surgical treatment methods such as Trans-Urethral Resection of Prostate (TURP) is also known to have common side effects such as TUR Syndrome etc. There are many studies and treatment methods described in Ayurvedic texts that are known to improve the condition with little or no side-effects. This study aims to define an effective treatment module for BPH management which will be used as a standard.

**OBJECTIVES:**

**Primary:**

To assess the efficacy of a Treatment Module including *Shodhana* followed by *Shamana* in maintaining the normal urine flow in patients of Benign Prostatic Hyperplasia.

**Secondary:**

To reduce Prostate Size

To reduce Prostate weight

To improve IPSS in patients of BPH

To validate a Module designed for management of BPH

**INVESTIGATIONS**

Prostate Specific Antigen (PSA) level before and after treatment

Routine & Microscopic test of Urine

Ultrasonography of Prostate Gland – before and after treatment

Post Voidal Residual Volume – before and after treatment

Other investigations such as Renal Function Test, FBS, PPBS

**CRITERIA FOR ASSESSMENT**

International Prostate Symptom Score (IPSS)

Uroflowmetry – before and after treatment to assess the peak flow rate

Post Voidal Residual Urine Volume

Gradation of Prostate Size

Gradation of Prostate Weight

Prostate Specific Antigen (PSA) Levels

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-04
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

• Patients diagnosed with BPH Grade I, II or III.
• Patients having classical signs and symptoms of Mutraghata.
• Patients fit for Anulomana and Uttara Basti.

Exclusion Criteria

• Age below 40 years or above 80 years 2.
• Patients with malignancy, congenital deformities of urogenital tract or any pathology other than BPH 4.
• Patients with Diabetes Mellitus, Hypertension, Renal disorders or any other systemic disease 5.
• Patients unfit for Anulomana and Uttara Basti.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient is able to maintain normal urine flow	0th Day, 21st Day, 41st Day, 60th Day

Secondary Outcome Measures

Name	Time	Method
Reduction in Prostate size	0th Day, 60th Day
Reduction in Prostate Weight	0th Day, 60th Day
Improvement in International Prostate Symptom Score (IPSS)	0th Day, 21st Day, 41st Day, 60th Day

Trial Locations

Locations (1)

All India Institute of Ayurveda; 🇮🇳 South, DELHI, India

All India Institute of Ayurveda

🇮🇳South, DELHI, India

Abhijeet Dahiya

Principal investigator

7042439876

dr.abhijeetdahiya@gmail.com