A clinical study to see the effect of some Ayurvedic formulations in the patients of Prostate enlargement.

Phase 2

Recruiting

Conditions: Benign Prostate Hypertrophy (BPH)

Registration Number: CTRI/2012/04/002586

Lead Sponsor: Department of AYUSH Ministry of Health Family Welfare Government of India

Brief Summary: Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country.

**Kanchanara Guggulu** is a poly herbal preparation containing Kanchanara (Bauhinia variegata), Haritaki (Terminalia chebula), Bibhitaka (Terminalia bellerica), Amlaki (Phyllanthus emblica), Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Varuna (Crataeva nurvala), Ela (Elettaria cardamomum), Tvak (Cinnamomum zeylanicum), Patra (Cinnamomum tamala) and Guggulu (Commiphora wightii).

**Varuna Kwath Churna** consists of dried stem bark of Crataeva nurvala.

The present study is being undertaken in three post graduate Ayurveda colleges to scientifically study and validate the clinical efficacy and safety of **Kanchanara Guggulu and Varuna Kwath Churna,** the classical Ayurvedic formulations which have been in use since ages and found to be useful in treating Benign Prostate Hypertrophy and promoting the health.

The **Central Council for Research in Ayurvedic Sciences (CCRAS)** is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Male

Target Recruitment: 150

Inclusion Criteria

Patients with age between 45 and 70 years.
Patients with American Urology Association (AUA) symptom score > 8 and < 21 3.
Rectal examination consistent with Benign Prostate Hypertrophy (BPH) 4.
Prostate volume > 30cc 5.
Prostate Specific Antigen (PSA) < 4 ng/ml 6.
Urine flow rate of >5 to <15ml/sec for 2 voids 7.
Willing and able to participate in the study for 16 weeks.

Exclusion Criteria

Patients with severe Benign Prostate H (AUA score >21) 2.
Patients currently using any other form of medical therapy for BPH/ Hair loss 3.
Patients with H/O Transurethral Resection of Prostate (TURP) 4.
Serum Prostate Specific Antigen (PSA) > 4 ng/ml 5.
Refractory bacteriuria 7.
Patients with persistent gross haematuria 8.
Patients with evidence of malignancy 9.
Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%) 10.
Patients with poorly controlled Hypertension ( > 11.
Patients on prolonged (> 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc.
or any other drugs that may have an influence on the outcome of the study.
160 / 100 mm Hg) 12.
Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.) 13.
Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S.
Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
Alcoholics and/or drug abusers.
H/o hypersensitivity to any of the trial drugs or their ingredients.
Patients who have completed participation in any other clinical trial during the past six (06) months.
Any other condition which the Principal Investigator thinks may jeopardize the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â€¢ Change in AUA symptom score during the period of 12 weeks.	AUA scoring is done at Baseline, at 14th day, at 28th day, at 42nd day, at 56th day, at 70th day, at 84th day andat the end of follow up at 16 weeks. \| QOL score is done at Baseline, at 84th day and at the end of follow up period at 16 weeks.
â€¢ Change in Quality of Life (QOL) Index.	AUA scoring is done at Baseline, at 14th day, at 28th day, at 42nd day, at 56th day, at 70th day, at 84th day andat the end of follow up at 16 weeks. \| QOL score is done at Baseline, at 84th day and at the end of follow up period at 16 weeks.

Secondary Outcome Measures

Name	Time	Method
â€¢ Reduction in the post voidal residual volume of urine	â€¢ Improvement in Peak urine flow rate.

Trial Locations

Locations (3): National Institute of Ayurveda (NIA), Jaipur
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Jaipur, RAJASTHAN, India
Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola
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Kangra, HIMACHAL PRADESH, India
Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Hassan
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Hassan, KARNATAKA, India
National Institute of Ayurveda (NIA), Jaipur
🇮🇳Jaipur, RAJASTHAN, India
Dr M K Shringi DrSunil Kanodiya
Principal investigator
09829194634
drshringi1@yahoo.co.in