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

Phase 2/3

Recruiting

• Conditions: Benign prostatic hyperplasia. Ayurveda Condition: VATASHTHILA,

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

Brief Summary

Benign ProstaticHyperplasia (BPH) is a common problem that affects the quality of life inapproximately one-third of men older than 50 years. BPH is histologicallyevident in up to 90% of men by age 85. The primary symptom of BPH is thehesitancy of micturition, poor prolonged flow, and a sensation of incompleteemptying of the Urinary bladder; it is due to increased prostate gland volume.Alpha-adrenoceptor blockers (e.g., Alfuzocin, tamsulosin) and fivealpha-reductase inhibitors are commonly used to treat LUTS attributed to BPH. They have adverseeffects like dizziness, asthenia, postural hypotension, syncope, sexualdysfunction, infertility, mood disorders, gynecomastia, highâ€grade prostatecancer, breast cancer, and cardiovascular morbidity/risk factors.  Prostatectomy and TURP are widely usedsurgical interventions in treating BPH, it also causes many complications.

Lower Urinary TractSymptoms (LUTS) associated with BPH are also described in Ayurveda classicaltexts under the heading of *Mutraghata.* Incomplete emptyingand hesitancy are the symptoms of *Vatasthila*, *Vatakundalika,*and*Vatabasti;weak* stream and strainingare the symptoms of*Mutratita,*andUrgencyis a symptom of *Vatabasti.*

Chandraprabha vati andGokshuradi Guggulu is very well known medicine in the management for thedisease (Lower urinary tract symtoms) of mutravahastrotas. Chandraprabha vatiis described for the management of Mutraghata in Yogaratnakara as well asGokshuradi Guggulu is described for the treatment of Mutraghata in SarangdharaSamhita.  Combination of Chandraprabhavati and Gokshuradi Guggulu is used in the management of BPH in Generalclinical practice.

this isa open-labelled randomised clinical trial with active control. Sample size ofthe trial is 70. This study will be conducted at RARI, Jammu.

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Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-07
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

• 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

• 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%).
• 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.
• 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.
• 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)	03 Months
•Changes in prostate volume, post-void residual (PVR), Maximum flow rate, Mean flow rate	03 Months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Regional Ayurveda Research Institute, Jammu; 🇮🇳 JAMMU, & KASHMIR, India

Regional Ayurveda Research Institute, Jammu

🇮🇳JAMMU, & KASHMIR, India

Dr Aaditya Bhavanbhai Shah Research Officer Ay

Principal investigator

9033236720

draaditya.shah@gov.in