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CTRI Number  CTRI/2022/12/048226 [Registered on: 19/12/2022] Trial Registered Prospectively
Last Modified On: 22/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   HOMOEOPATHIC IN BENIGN PROSTATIC HYPERPLASIA 
Scientific Title of Study   A PROSPECTIVE STUDY ON THE EFFECT OF HOMOEOPATHIC MEDICINES IN THE MANAGEMENT OF BENIGN PROSTATIC HYPERPLASIA BY ASSESSING ULTRASONOGRAM (ABDOMEN) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manusree K M 
Designation  Junior resident  
Affiliation  Government Homoeopathic Medical Collage. 
Address  Department of practice of medicine . Government Homoeopathic Medical Collage. Kozhikode pin-673010 state - kerala

Kozhikode
KERALA
673010
India 
Phone  9656606923  
Fax    
Email  manusree1010@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lizmy Jose 
Designation  Professor (CAP) 
Affiliation  Government Homoeopathic Medical Collage. 
Address  Department of practice of medicine . Government Homoeopathic Medical Collage. Kozhikode pin-673010 state - kerala

Kozhikode
KERALA
673010
India 
Phone  9747551747  
Fax    
Email  lizmyajith@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manusree K M 
Designation  Junior resident  
Affiliation  Government Homoeopathic Medical Collage. 
Address  Department of practice of medicine . Government Homoeopathic Medical Collage. Kozhikode pin-673010 state - kerala

Kozhikode
KERALA
673010
India 
Phone  9656606923  
Fax    
Email  manusree1010@gmail.com  
 
Source of Monetary or Material Support  
GOVERNMENT HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL KOZHIKODE  
 
Primary Sponsor  
Name  Dr.Manusree K M 
Address  Department of Practice of Medicine, Govt Homoeopathic Medical College, Kozhikode. PIN - 673010 Kerala 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manusree K M  Govt Homoeopathic Medical College, Kozhikode.   Renal OP Ground floor New block Govt Homoeopathic Medical College and hospital, Kozhikode. pin - 673010 Kerala
Kozhikode
KERALA 
9656606923

manusree1010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee govt, homeoepathic medical college , kozhikode  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HOMOEOPATHIC MEDICINES   Suitable homoeopathic medicines based on symptom totality dose and potency will be selected on the basis of homeopathic principles route of administration will be oral duration of treatment will be 1 year 
Comparator Agent  not applicable   not applicable  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  1. Those cases above 40 years of age with symptoms of Benign Prostatic Hyperplasia.
2. Cases with positive ultrasound scan finding. 
 
ExclusionCriteria 
Details  1. History of prostatitis , Prostate CA , Bladder CA
2. BPH with complications.
3 .Cases with serum PSA level above 10 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
change in Ultra sonographical findings in patients with Benign
prostatic hyperplasia before and after treatment with homoeopathic medicines .
change in international prostate symptom score in patients with
Benign prostatic hyperplasia before & after homoeopathic treatment.
 
6 month 
 
Secondary Outcome  
Outcome  TimePoints 
change in international prostate symptom score in patients with
Benign prostatic hyperplasia before & after homoeopathic treatment.
 
1 year 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   23/12/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/12/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   INTRODUCTION 

Benign prostatic hyperplasia (BPH) is one of the most common diseases in ageing men which can lead to lower urinary tract symptoms (LUTS)(1) Autopsy studies have observed a histological prevalence of 8%, 50%, and 80% in the 4th, 6th, and 9th decades of life, respectively Incremental increase is greater in Africa, Asia, Latin America and the Caribbean regions there is decreased risk among the Asians compared to the western white population. Genetics, diet and life style may play a role here.  Globally, the estimated incidence case of BPH in 2019 was 11.26 million (95%UI: 8.79, 14.46), increasing from 5.48 million (95%UI: 4.20, 7.12) in 1990. Proliferation of both stromal and epithelial cells of the prostate in the transitional zone around the urethra characterises BPH, which frequently results in lower urinary tract symptoms such as incontinence  ● Voiding symptoms - hesitancy (worsened if the bladder is very full) , poor flow (unimproved by straining) , intermittent stream – stops and starts , dribbling (including after micturition) , sensation of poor bladder emptying , episodes of near retention. ● Storage symptoms - frequency , nocturia , urgency , urge incontinence , nocturnal incontinence (enuresis) . Risk factors of BPH include age, family history, obesity, Type 2 Diabetes, sedentary life and erectile dysfunction. BPH is diagnosed based on symptoms and examination after ruling out other possible causes.  BPH is diagnosed with the digital rectal examination(DRE), cystoscopy, trans abdominal & trans rectal prostate ultrasound and urodynamic, prostate-specific antigen(PSA), urinalysis and culture and bladder ultrasound. Transabdominal pelvic ultrasonography is a tremendously versatile tool and it is a non invasive method for evaluating the lower urinary tract and prostate in men and the bladder in women. Severity of symptoms can be ascertained by using International Prostate Symptom Score questionnaire [IPSS] Non-medicinal management were advised: To urinate when they first got the urge ; To discontinue tobacco, alcohol and caffeine, especially after dinner ; Not to drink a lot of fluid at once and to avoid drinking fluids within two hours of bed time; Not to take overthe-counter cold and sinus medications that contain decongestants and antihistamines, As these can increase BPH symptoms; to keep themselves warm by exercising regularly and to reduce stress , nervousness and tension which lead to more frequent urination; to perform Kegel exercises for strengthening pelvic muscles. BPH is associated with quality of life issues, it is not life-threatening, and it does not lead to prostate carcinoma.
 RATIONALE OF THE STUDY

 Homoeopathy is the second-most widely used Complementary and alternative medicine (CAM) in healthcare systems according to the World Health Organization. The Central Council for Research in Homoeopathy (CCRH) had carried out preliminary study on symptomatic BPH with positive effects. The Council then took up a multi-centre study to evaluate the usefulness of a group of pre-defined homoeopathic medicines in BPH patients as a primary objective. The secondary objective was to check the progression of disease by evaluating changes in prostate volume (PV), post-void residual urine (PVRU) and peak urine flow rates (Qmaximum and Qaverage in mL/sec).But In this study, it is observed that homeopathic medicines were able to change significantly the PV, maintain serum PSA till 12 months of treatment but no change was observed in post-void residual urine, Qmax and Qavg. Medical Management in modern medicine is with alpha adrenoreceptor blockers, but it causes reflex tachycardia, cardiac arrhythmia and retrograde ejaculation and there is a marked increase in incidence of Benign Prostatic Hyperplasia in India due to rapid urbanization and lifestyle changes. α1 adrenergic receptor blockers are not able to significantly alter PSA, and PV. There are only a few studies conducted in homoeopathy in this topic. As homoeopathy is a system on wholistic approach, we can effectively manage Benign Prostatic Hyperplasia. Most of the researches in homoeopathy reduced the lower urinary tract symptoms , but no change was observed in post residual urine. Therefore this study is a humble effort to check the progress of BPH by evaluating ultrasonographic findings & International prostate symptom score with homoeopathic medicines.
 
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