| CTRI Number |
CTRI/2018/05/013584 [Registered on: 01/05/2018] Trial Registered Prospectively |
| Last Modified On: |
01/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Homeopathic treatment of enlarged prostate |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicines and mother tinctures in benign prostatic hypertrophy: an open randomized pragmatic trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abijit Chattopadhyay |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
OPD room no. 12 and 13, Dept. of Homoeopathic Materia Medica; Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
7003547446 |
| Fax |
|
| Email |
drac.nih@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chintamani Nayak |
| Designation |
Lecturer |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
OPD room no. 12 and 13, Dept. of Homoeopathic Materia Medica; Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chintamani Nayak |
| Designation |
Lecturer |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
OPD room no. 12 and 13, Dept. of Homoeopathic Materia Medica; Block GE, Sector III, Salt Lake, Kolkata
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India; Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy Ministry of AYUSH Govt of India |
| Address |
Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Abhijit Chattopadhyay |
National Institute of Homoeopathy, Govt. of India |
OPD room no. 12 and 13, Dept. of Homoeopathic Materia Medica; Block GE,
Sector III, Salt Lake,
Kolkata 700106
Kolkata
WEST BENGAL |
7003547446
drac.nih@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Benign Prostatic Hypertrophy (BPH), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hydrangea arborescens or Sabal serrulata mother tincture |
Mother tinctures (Hydrangea arborescens or Sabal serrulata) will be administered in personalized dosage (10-20 drops once-thrice daily in half cup of normal water); be taken orally on clean tongue with empty stomach. Duration of therapy: 6 months |
| Intervention |
Indicated homeopathic medicines in centesimal or fifty millesimal potencies |
Indicated homeopathic medicines in centesimal or fifty millesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of a single drop of the indicated medicine (preserved in 90% v/v ethanol) in 5 ml of distilled water; dosage and repetition depending upon the individual requirement of the cases. In 50 millesimal scale, a single medicated cane sugar globules of poppy seed size (no. 10) shall be dissolved in 90 ml distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. Medicines are to be taken orally on clean tongue with empty stomach. Duration of therapy: 6 months |
| Comparator Agent |
Individualized homeopathic medicines plus Hydrangea arborescens or Sabal serrulata mother tincture |
Indicated homeopathic medicines in centesimal or fifty millesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of a single drop of the indicated medicine (preserved in 90% v/v ethanol) in 5 ml of distilled water; dosage and repetition depending upon the individual requirement of the cases. In 50 millesimal scale, a single medicated cane sugar globules of poppy seed size (no. 10) shall be dissolved in 90 ml distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. Along with this, Mother tinctures (Hydrangea arborescens or Sabal serrulata) will be administered in personalized dosage (10-20 drops once-thrice daily in half cup of normal water); be taken orally on clean tongue with empty stomach. Duration of therapy: 6 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. Age 30-80 years
2. Presenting symptoms of prostatism, with or without evidence of bladder outflow obstruction [AUASS > 7]
3. Ultrasonographic examination prostate weight > 20 g/20 cc and RUV of > 30 ml
4. Patients already undergoing regular therapy for BHP, provided the medications are stopped completely at least 2 weeks prior study entry
5. Ability to read English or Bengali
6. Providing written informed consent to participate |
|
| ExclusionCriteria |
| Details |
1. Patients not adequately symptomatic [AUASS < 7]
2. Patients with serum prostate specific antigen (PSA) > 4 nmol/mL to rule out suspected prostatic malignancy
3. Complete urinary retention/stone formation
4. Gross bilateral hydronephrosis
5. Other possible causes of urinary retention, such as recurrent urinary tract infection, neurogenic bladder or urethral stricture
6. Patients insisting for surgery during the next 6 months
7. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any vital organ failure
8. Substance abuse and/or dependence
9. Self-reported immune-compromised state
10. Undergoing homeopathic treatment for any chronic disease within last 6 months
11. Patients who are too sick for consultation and not willing to cooperate
12. Unable to read patient information sheet
13. Unwilling to take part and not giving consent to join the study |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Translated Bengali version of American Urology Association Symptom Score (AUASS) |
At baseline, after 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prostate size and RUV |
At baseline and after 6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3 |
|
Date of First Enrollment (India)
|
02/05/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet; to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Benign Prostatic Hyperplasia (BPH) is the most common condition in ageing men, associated with Lower Urinary Tract Symptoms (LUTS). The prevalence of BPH increases with age. The lifetime risk of developing histological confirmed BPH has been approximately 8% between the age 31 to 40 years, 50% between 51 to 60 years, 70% between 61 to 70 years and 90% between 81 to 90 years. Correspondingly, symptomatic (clinical) BPH is present in approximately 26% of the men in the fifth decade, 33% in the sixth decade, 41% in the seventh decade and 46% in the eighth decade of life and beyond. There is sufficient homeopathic literature wherein a number of constitutional as well as organopathic medicines are listed for the treatment of BPH. In a clinical trial conducted by AK Hati, et al, 2012 on 180 patients comparing the homeopathic treatment strategies using Constitutional Medicines (CM) or Organopathic Medicines (OM) alone or in combination of both Constitutional and Organopathic Medicines (BCOM) in patients suffering from BPH reports the highest treatment response in patients prescribed BCOM. However, this study was not randomized and instead sequentially allocated. The authors consider it very important to replicate the study in similar design, but with enhanced methodological rigor. In this open, randomized, prospective, three parallel arms, pragmatic trial, 120 patients suffering from symptomatic BPH will be randomized to either individualized homeopathic medicines (n=40), or mother tincture (n=40), or individualized homeopathic medicines plus mother tincture (n=40). Outcomes will be measured in terms of AUASS, prostate size and RUV, measured at baseline, after 3 months and 6 months. Comparative analysis will be carried out in the end to detect group differences, if any. Results will be published in scientific journals. |