| CTRI Number |
CTRI/2024/12/078479 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on Effectiveness of Homoeopathic medicine in the treatment of Male sexual problem, Erectile Dysfunction-
|
|
Scientific Title of Study
|
A Prospective interventional study on effectiveness of individualized Homoeopathic medicine in the treatment of Erectile Dysfunction- By using The international index of erectile function (IIEF)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PARTHA SARATHI MANDAL |
| Designation |
PROFESSOR |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY, P.O LIMDA, WAGHODIA, VADODARA
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY, P.O LIMDA, WAGHODIA, VADODARA
Vadodara
GUJARAT
391760
India |
| Phone |
9375095471 |
| Fax |
|
| Email |
mandal_parthasarathi@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. VIPUL S SHASTRI |
| Designation |
PROFESSOR |
| Affiliation |
VIDHYADEEP HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
VIDHYADEEP HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE, VIDHYADEEP UNIVERSITY, ANITA, KIM
VIDHYADEEP HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH CENTRE, VIDHYADEEP UNIVERSITY, ANITA, KIM
Vadodara
GUJARAT
394110
India |
| Phone |
9824109174 |
| Fax |
|
| Email |
drvipulshastri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PARTHA SARATHI MANDAL |
| Designation |
PROFESSOR |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY, P.O LIMDA, WAGHODIA, VADODARA
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY, P.O LIMDA, WAGHODIA, VADODARA
Vadodara
GUJARAT
391760
India |
| Phone |
9375095471 |
| Fax |
|
| Email |
mandal_parthasarathi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY, P.O LIMDA, WAGHODIA, VADODARA 391760 |
|
|
Primary Sponsor
|
| Name |
PRINCIPLE INVESTIGATOR |
| Address |
Jawaharlal Nehru Homoeopathic Medical College
Parul University, P.O.Limda, Ta.Waghodia,, Dist. Vadodara, Vadodara, Gujarat 391760 |
| Type of Sponsor |
Other [DR. PARTHA SARATHI MANDAL] |
|
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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 POORAV DESAI |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE HOSPITA |
Room no. 205,JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE HOSPITA, PARUL UNIVERSITY, P.O LIMDA, WAGHODIA, VADODARA 391760
Vadodara
GUJARAT |
9227623023
poorav.desai@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND INNOVATION UNIT , INTERNAL ETHICAL COMMITTEE,VIDHYSDEEP UNIVERSITY |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HOMOEOPATHIC INDIVIDUALIZED MEDICINE |
Oral Dose BDS
6 Months duration of treatment
Patient enrollment continue for 6 month
Assessment of outcome will be done at every 6 months. |
| Comparator Agent |
not applicable |
not applicable |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Cases were randomly selected from the adult male of 18-60 age group
Prediagnosed and cases having the clinical features of Ed should be included.
|
|
| ExclusionCriteria |
| Details |
Age bellow 18 yrs. And above 60yrs.
Cases which requires surgical treatment.
Cases with severe mental or physical illness, bedridden patient
Cases with irregular follow up
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in ERECTILE DISFUNCTION of the patient as per IIEF SCALE |
12 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effect of different potencies in ED.
To study effect of Homoeopathic individualized medicine on underlying cause of ED
|
1yr |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/12/2024 |
| 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="1"
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
|
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Brief Summary
|
A Prospective interventional study on ROLE of individualized Homoeopathic medicine in the treatment of Erectile Dysfunction- By using The international index of erectile function (IIEF) To study the effectiveness of Individualized Homoeopathic medicine in the treatment of erectile dysfunction. OBJECTIVES To study the comparative usefulness of individualized Homoeopathic medicine and placebo in ED. To study the effect of different potencies in ED. To study effect of Homoeopathic individualized medicine on underlying cause of ED
Null hypothesis(Ho): Homoeopathic individualized medicine is not effective in treating ED Alternative hypothesis(H1): Homoeopathic individualized medicine is effective in treating ED
METHODS OF COLLECTION OF DATA:
The study was performed in following ways: Type of study: Prospective , Interventional Method of sampling: Purposive sampling. Number of samples: 100 cases
Inclusion criteria: Cases were randomly selected from the adult male of 18-60 age group Prediagnosed and cases having the clinical features of Ed should be included.
Exclusion criteria: Age bellow 18 yrs. And above 60yrs. Cases which requires surgical treatment. Cases with severe physical illness, bed ridden patient Cases with irregular follow up
|