| CTRI Number |
CTRI/2021/09/036271 [Registered on: 06/09/2021] Trial Registered Prospectively |
| Last Modified On: |
02/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
It is a study on patient having lumbago using phatak repertory. |
|
Scientific Title of Study
|
AN INTERVENTIONAL STUDY TO ASSESS THE CLINICAL UTILITY OF
PHATAK’S REPERTORY
IN CASES OF LUMBAGO USING RDQ SCORE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Mishra |
| Designation |
MD Scholar |
| Affiliation |
DR MADAN PRATAP KHUNTETA HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, |
| Address |
DR MADAN PRATAP KHUNTETA HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, SAIPURA, SHIKARPURA, SANGANER, JAIPUR
DR MADAN PRATAP KHUNTETA HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, SAIPURA, SHIKARPURA, SANGANER, JAIPUR
Jaipur
RAJASTHAN
302029
India |
| Phone |
9950344538 |
| Fax |
|
| Email |
Mishra030197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Shamra |
| Designation |
MD |
| Affiliation |
DR MADAN PRATAP KHUNTETA HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, |
| Address |
DR MADAN PRATAP KHUNTETA HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, SAIPURA, SHIKARPURA, SANGANER, JAIPUR
DR MADAN PRATAP KHUNTETA HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, SAIPURA, SHIKARPURA, SANGANER, JAIPUR
Jaipur
RAJASTHAN
302029
India |
| Phone |
9783318494 |
| Fax |
|
| Email |
Yashasvi119@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swati Mishra |
| Designation |
MD Scholar |
| Affiliation |
DR MADAN PRATAP KHUNTETA HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, |
| Address |
DR MADAN PRATAP KHUNTETA HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, SAIPURA, SHIKARPURA, SANGANER, JAIPUR
DR MADAN PRATAP KHUNTETA HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, SAIPURA, SHIKARPURA, SANGANER, JAIPUR
Jaipur
RAJASTHAN
302029
India |
| Phone |
9950344538 |
| Fax |
|
| Email |
Mishra030197@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR MADAN PRATAP KHUNTETA HOMOEOPATHIC MEDICAL COLLEGE. HOSPITAL AND RESEARCH CENTRE, JAIPUR (A CONSTITUENT COLLEGE OF HOMOEOPATHIC UNIVERSITY) 10,11,12, HAHNEMANN MARG, DIGGI MALPURA ROAD, SAIPURA, SHIKARPURA, SANGANER, JAIPUR-302029. |
|
|
Primary Sponsor
|
| Name |
Swati Mishra |
| Address |
DR MADAN PRATAP KHUNTETA HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, JAIPUR (A CONSTITUENT COLLEGE OF HOMOEOPATHIC UNIVERSITY) 10,11,12, HAHNEMANN MARG, DIGGI MALPURA ROAD, SAIPURA, SHIKARPURA, SANGANER, JAIPUR-302029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Swati Mishra |
DR MADAN PRATAP KHUNTETA HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, JAIPUR . |
10,11,12, HAHNEMANN MARG, DIGGI MALPURA ROAD, SAIPURA, SHIKARPURA, SANGANER, JAIPUR-302029.
Jaipur
RAJASTHAN |
9950344538
Mishra030197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee Homoeopathy University, Jaipur |
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: M958||Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine |
Homoeopathic medicine selected by Phatak repertory |
| Comparator Agent |
Roland Morris Disability Questionnaire. |
The Roland Morris disability questionnaire is constructed by choosing statements from the sickness impact profile (SIP). The scale consists of 24 yes/ no items related specifically assess the disability from LBP. Patients are asked whether the following (given below) statements apply to them. In this scale one point is given for each item. The RDQ score can be obtained by adding up the number of items checked. The final score ranges from 0 (no disability) to 24 (severe disability). |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
•All age groups.
•Both sexes
•Chronic cases of lumbago with acute exacerbations.
•Cases giving consent to participate in study. |
|
| ExclusionCriteria |
| Details |
•Pregnant women and lactating women are not included in the study.
•patients which are not curable homoeopathically like ankylosing spondylitis, paget’s disease, etc.
•patients with severe complications.
•Patient who are not willing to give the consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• The study will help to assess the pain relieve in symptoms of chronic lumbago and in cases of acute exaggeration.
• To verify clinical utility of Phatak repertory in cases of lumbago. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • The study will help to assess the pain relieve in symptoms of chronic lumbago and in cases of acute exaggeration. |
8weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
07/09/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/09/2021 |
| 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
|
no publications yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an interventional study to assess the clinical utility of Phatak repertory in management of cases of lumbago using RDQ score scale for 12 month in 40 patient. The study is conducted at Dr MPK Homoeopathic Medical College, Hospital, Research Centre.
|