| CTRI Number |
CTRI/2020/04/024670 [Registered on: 16/04/2020] Trial Registered Prospectively |
| Last Modified On: |
12/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Individualization with the help of PULSE (Nadi) |
|
Scientific Title of Study
|
TO STUDY ‘PULSE CHAPTER’ FROM “HOMOEOPATHIC MEDICAL REPERTORY BY ROBIN MURPHY†AND SHOWING ITS UTILITY IN PRESCRIBING TOTALITY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr mansi shinde |
| Designation |
PG STUDENT |
| Affiliation |
Dr J J MAGDUM HOMOEOPATHIC MEDICAL COLLEGE JAYSINGPUR |
| Address |
Dr J J Magdum homoeopatrhic medial college and hospital jaysingpur, Opd NO- 3, Block No- 1, Floor No1, maharashtra
Kolhapur
MAHARASHTRA
416101
India |
| Phone |
7709140142 |
| Fax |
|
| Email |
mansishinde1805@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M A Mhaishale |
| Designation |
Professor |
| Affiliation |
Dr J J MAGDUM HOMOEOPATHIC MEDICAL COLLEGE JAYSINGPUR |
| Address |
Dr J J Magdum homoeopatrhic medial college and hospital jaysingpur, Opd NO- 3, Block No- 1, Floor No1, maharashtra
Kolhapur
MAHARASHTRA
416101
India |
| Phone |
9981755345 |
| Fax |
|
| Email |
dr.mamhaishale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M A Mhaishale |
| Designation |
Professor |
| Affiliation |
Dr J J MAGDUM HOMOEOPATHIC MEDICAL COLLEGE JAYSINGPUR |
| Address |
Dr J J Magdum homoeopatrhic medial college and hospital jaysingpur, Opd NO- 3, Block No- 1, Floor No1, maharashtra
Kolhapur
MAHARASHTRA
416101
India |
| Phone |
9981755345 |
| Fax |
|
| Email |
dr.mamhaishale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr J J Magdum homoeopatrhic medial college and hospital jaysingpur, maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Mansi Shinde |
| Address |
Plot no 38 kamalapati colony sambhajipur jasyingpur 416101 |
| 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 Mansi Shinde |
Dr J J MAGDUM HOMEOPATHIC MEDICAL COLLEGE HOSPITAL JAYSINGPUR |
Dr J J Magdum homoeopatrhic medial college and hospital jaysingpur, Opd NO- 3, Block No- 1, Floor No1, maharashtra
Kolhapur
MAHARASHTRA |
7709140142
mansishinde1805@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr J J MAGDUM HOMEOPATHIC MEDICAL COLLEGE HOSPITAL IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Homoeoparhic medicine or placebo |
200 c,
oral administration,
stat dose and repetation if need |
| Intervention |
Homoeopathic drug |
200 c, oral administration, stat dose and repetation if need |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both sexes will be considered.
2. Patients onwards 10 years of age.
3. Patient having scope for pulse study.
|
|
| ExclusionCriteria |
| Details |
1. Patient having any congenital heart disease, (PA shunt,)
2.Any Pathogical Diseases having Indirect influence on blood vessels {Diabetes and its complication, gas gangrene, Thyro- toxicosis etc.}
3. Cases requiring emergency management, surgical intervention &cases with gross pathology will be excluded.
4. Patient having Arterial Flatter, Supraventricular tachycardia, Acquired immune Deficiency Syndrome are excluded.
5 .Pregnant women and lactating mothers are excluded.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study pulse chapter from ‘‘Homoeopathic Medical Repertory by Robin Murphy’’ to find out its importance in prescribing totality |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study pulse chapter from ‘‘Homoeopathic Medical Repertory by Robin Murphy’’ |
18 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2020 |
| Date of Study Completion (India) |
01/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pulse is integral part of human study and since ancient time in india as NADI PARIKSHAN so i like to explore the same use in Homoeopathic view. As well will be published as thesis and research artical peer reviewed reasearch artical |