| CTRI Number |
CTRI/2024/08/072945 [Registered on: 23/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of Individualized Homoeopathic Medicines Vs Conium maculatum in Prostatic enlargement |
|
Scientific Title of Study
|
Double Blind Controlled Trial In Benign Prostatic Hyperplasia Using Individualized Homoeopathic Medicine And Homoeopathic Dilution Of Conium Maculatum - A Two Arm Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gouri Krishnan H |
| Designation |
Post Graduate Scholar, Department Of Practice Of Medicine |
| Affiliation |
National Homoeopathy Research Institute In Mental Health |
| Address |
Department of Practice of Medicine, National Homoeopathy Research Institute In Mental Health, Sachivothamapuram (P.O), Kurichy
Kottayam
KERALA
686532
India |
| Phone |
6282109254 |
| Fax |
|
| Email |
gouri002010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S G S Chakravarthy |
| Designation |
Professor, Department Of Practice Of Medicine |
| Affiliation |
National Homoeopathy Research Institute In Mental Health |
| Address |
Department of Practice of Medicine, National Homoeopathy Research Institute In Mental Health, Sachivothamapuram (P.O), Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9908019739 |
| Fax |
|
| Email |
sgschakravarthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S G S Chakravarthy |
| Designation |
Professor, Department Of Practice Of Medicine |
| Affiliation |
National Homoeopathy Research Institute In Mental Health |
| Address |
Department of Practice of Medicine, National Homoeopathy Research Institute In Mental Health, Sachivothamapuram (P.O), Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9908019739 |
| Fax |
|
| Email |
sgschakravarthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute In Mental Health, Sachivothamapuram (P.O), Kurichy, Kottayam, Kerala, 686532, India |
|
|
Primary Sponsor
|
| Name |
Dr Gouri Krishnan H |
| Address |
National Homoeopathy Research Institute In Mental Health, Sachivothamapuram (P.O), Kurichy, Kottayam, Kerala, 686532, India |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Dr Gouri Krishnan H |
National Homoeopathy Research Institute In Mental Health |
Outpatient and Inpatient departments, Peripheral centers and Camps conducted under Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (P.O), Kurichy, Kottayam
Kottayam
KERALA |
6282109254
gouri002010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee- National Homoeopathy Research Institute in Mental Health, Kottayam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N40||Benign prostatic hyperplasia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conium maculatum |
Conium maculatum will be given orally in 4 globules of No.40 size in centesimal scale potency starting from 6C to 50M as per the need of the case. The repetition will be adjusted as per the necessity of the follow – up. The above treatment will be given for a period of 10 months. In case of any acute illness, the acute totality shall be taken and medicine will be prescribed and documented accordingly. |
| Intervention |
Individualized Homoeopathic Medicine |
The selected medicine will be given orally in 4 globules of No.40 size in centesimal scale potency starting from 6C to 50M as per the need of the case. The repetition and change of the remedy will be adjusted as per the necessity of the follow – up.
The above treatment will be given for a period of 10 months. In case of any acute illness, the acute totality shall be taken and medicine will be prescribed and documented accordingly. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1.Male patients within the age group 40 to 80 years
2.Cases with positive ultrasound findings of BPH
|
|
| ExclusionCriteria |
| Details |
1.Chronic prostatitis/Prostate abscess/Ca prostate/ History of any malignancies
2.PSA greater than 4 ng/mL
3.Other cases of Urinary retention greater than 24hrs/ Recurrent gross hematuria/Bladder stone/ Recurrent UTI/Urethral stricture.
4.Known cases of serious systemic illnesses like Uncontrolled Diabetes Mellitus, Malignancies, Malignant Hypertension, Severe cardiac diseases
5.Cases that are under other medications for BPH
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Prostatic Volume (PV) in Ultrasound scan |
Baseline, 5th month and at the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes in Post Void Residual Urine (PVRU) Volume in Ultrasound scan
2.Changes in International Prostate Symptom Score (IPSS) |
1.Baseline, 5th month and at the end of the study
2.Every month from baseline to the end of the study |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
02/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Double Blind Controlled Trial in Benign Prostatic Hyperplasia using Individualized Homoeopathic Medicine and Homoeopathic Dilution of Conium maculatum - a two arm Randomized Controlled Trial, that will be conducted in the Outpatient and Inpatient departments, Peripheral centers and Camps conducted under the Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, Kottayam. The primary outcome measure will be, the changes in Prostatic Volume (PV) in Ultrasound scan which will be measured every 5 months (at Baseline, 5th month and at the end of the study). The secondary outcomes will be, changes in Post Void Residual Urine (PVRU) Volume in Ultrasound scan measured at Baseline, 5th month and at the end of the study and Changes in International Prostate Symptom Score (IPSS) measured every month from baseline to the end of the study. Since there hasn’t been any studies conducted solely to explore the effectiveness of Conium maculatum in Benign Prostatic Hyperplasia cases, conducting a double blind randomized controlled trial, may help in unveiling and exploring more therapeutic actions of Conium in this regard.
|