| CTRI Number |
CTRI/2024/04/065479 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Accuracy of Rhus Toxicodendron and Calcarea Fluorica in Heel Pain cases. |
|
Scientific Title of Study
|
To Verify The Efficacy Of Rhus Toxicodendron & Calcarea Fluorica In Cases Of Calcaneal Spur:Clinical Verification 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 DIVYABEN UTTAMBHAI PATEL |
| Designation |
PG STUDENT |
| Affiliation |
DR.V H DAVE HOMOEOPATHIC MEDICAL COLLEGE & SMT.S.I.PATEL(I) HOMOEOPATHIC HOSPITAL. |
| Address |
1048,AT-SUDHAWADI HARANGAM VAYA-RANKUVA, TA-CHIKHLI, DISTRICT - NAVSARI PIN NO.- 396560.
Dr.V.H.Dave Homoeopathic Medical College & Smt.S.I.Patel(Ipcowala)Homoeopathic Hospital Hahnemann House,Amul Dairy Road,Anand-388001
Navsari
GUJARAT
396560
India |
| Phone |
9624745084 |
| Fax |
|
| Email |
divya.patel3093@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SONAL PANCHMATIYA |
| Designation |
PROFESSOR |
| Affiliation |
DR V H DAVE HOMOEOPATHIC MEDICAL COLLEGE AND SMT.S.I.PATEL(I) HOMOEOPATHIC HOSPITAL |
| Address |
DR.V H DAVE HOMOEOPATHIC MEDICAL COLLEGE AND SMT S I PATEL(I) HOMOEOPATHIC HOSPITAL
HAHNEMANN HOUSE,AMUL DAIRY ROAD, ANAND -388001
DR.V H DAVE HOMOEOPATHIC MEDICAL COLLEGE AND SMT S I PATEL(I) HOMOEOPATHIC HOSPITAL
HAHNEMANN HOUSE,AMUL DAIRY ROAD, ANAND -388001
Anand
GUJARAT
388001
India |
| Phone |
9426432585 |
| Fax |
|
| Email |
dr.sonal2705@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DIVYABEN UTTAMBHAI PATEL |
| Designation |
PG STUDENT |
| Affiliation |
DR V H DAVE HOMOEOPATHIC MEDICAL COLLEGE AND SMT.S.I.PATEL(I) HOMOEOPATHIC HOSPITAL |
| Address |
1048,SUDHAWADI HARANGAM VAYA-RANKUVA,TA-CHIKHLI,DIST-NAVSARI,PIN NO-396560
DR.V H DAVE HOMOEOPATHIC MEDICAL COLLEGE AND SMT S I PATEL(I) HOMOEOPATHIC HOSPITAL
HAHNEMANN HOUSE,AMUL DAIRY ROAD, ANAND -388001
Anand
GUJARAT
396560
India |
| Phone |
9624745084 |
| Fax |
|
| Email |
divya.patel3093@gmail.com |
|
|
Source of Monetary or Material Support
|
| (1) SMT.S.I.PATEL(I) HOMOEOPATHIC HOSPITAL,AMUL DAIRY ROAD, ANAND. |
| (2)HOMOEOPATHIC DEPARTMENT AL-MEEZAN CHARITABLE TRUST OPERATED UNITY GENERAL HOSPITAL-BORSAD.DIST-ANAND |
|
|
Primary Sponsor
|
| Name |
DRDIVYABEN UTTAMBHAI PATEL |
| Address |
1048, AT-SUDHAWADI HARANGAM VAYA-RANKUVA TA-CHIKHLI DISTRICT - NAVSARI PIN NO.- 396560 |
| Type of Sponsor |
Other [(SELF)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR DIVYABEN UTTAMBHAI PATEL |
Homoeopathic Department Charitable trust unity general hospital Borsad Anand |
Homoeopathic Department AL-MEEZAN CHARITABLE TRUST Operated Unity General Hospital-Borsad.dist-Anand.
Anand
GUJARAT |
9624745084
divya.patel3093@gmail.com |
| DR DIVYABEN UTTAMBHAI PATEL |
smt s i patel homoeopathic hospital Anand. |
Dr.v.h.dave homoeopathic medical College & smt.s.i.patel (ipcowala) homoeopathic hospital Hahnemann house, amul dairy road, Anand - 388001
Anand
GUJARAT |
9624745084
divya.patel3093@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE VHDHMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M858||Other specified disorders of bonedensity and structure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Rhus Toxicodendron
Calcarea Fluorica |
The Symptoms will be Analysed & evaluated.
Totality of symptoms will be formed & compared with Totality of Rhus Toxicodendron & Calcarea Fluorica .
The Potency of Rhus Toxicodendron & Calcarea Fluorica will be selected depending upon the susceptibility of the patients.
Case will be reviewed every 7-15 days depending upon the requirements of the case. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
- CASES OF PREDIAGNISED OR CASES WITH CLINICAL PRESENTATION OF CALCANEAL SPUR WHERE RHUS TOXICODENDRON OR CALCAREA FLUORICA WILL BE INDICATED THROUGH SYMPTOMATOLOGY WILL BE INCLUDED IN THE STUDY.
-CASES ABOVE AGE OF 30 YEARS TO 70 YEARS IRRESPECTIVE OF GENDER
|
|
| ExclusionCriteria |
| Details |
PATIENTS WITH HISTORY OF PREVIOUS ANKLE FRACTUR PREVIOUS ANKLE SURGERY, INFLAMMATORY JOINT DISEASE, FOOT DEFORMITIES |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FOOT FUNCTION INDEX , 1991 , BUDIMAN-MAK,E |
Every 7-15 days or as per requirement of cases till 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/05/2024 |
| 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="0"
Months="9"
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
|
Calcaneal spur is a bony outgrowth forms on the heel bone.calcaneal spur can be located at the back of the heeldorsal heel spur or under the sole planter heel the dorsal spurs are often associated with Achilles tendinopathy,while spurs under the sole are associated with plantar facilities. The apex of the spur lies either within the origin of the plantar fascia on the medial tubercle of the calcaneal or superior to it in the origin of the flexor digitorum brevis muscle. Plantar calcaneal spur arise from medial or lateral tuberosity. Calcaneal spurs are fibro cartilaginous triangular projection that vary in size present on the calcaneum In this clinical trial, using of two medicines (1)- Rhus toxicodendron & (2) Calcarea fluorica So, Rhus toxicodendron and Calcarea fluorica are effective in clinical cases of calcaneal spur in 9 months duration in sample size of 44 between age group of 30-70 years irrespective of gender. Criteria of perticular case will be obtained with use of symptom score of foot function index. Statistical analysis will be done with paired t-test. |