| CTRI Number |
CTRI/2025/03/082445 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing the Effect of Guajacum Officinale on Joint Pain |
|
Scientific Title of Study
|
An interventional Study To Assess The Effectiveness Of Guajacum Officinale In The Cases Of Arthralgia |
| 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 Sachin Kumar Yadav |
| Designation |
PG Student |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Materia Medica
Dr MPK Homoeopathic medical college Hospital and Research Centre A constituent college of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
7877076255 |
| Fax |
|
| Email |
ysachin7877@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Tuteja |
| Designation |
Professor |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Materia Medica
Dr MPK Homoeopathic medical college Hospital and Research Centre A constituent college of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9530454132 |
| Fax |
|
| Email |
drsoniatuteja@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Kumar Yadav |
| Designation |
PG Student |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Materia Medica
Dr MPK Homoeopathic medical college Hospital and Research Centre A constituent college of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
7877076255 |
| Fax |
|
| Email |
ysachin7877@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Materia Medica Dr Girendra Pal Homoeopathic Hospital and Research Centre
Collegiate Hospital Of Dr MPK Homoeopathic Medical College Hospital and Research Centre A
Constituent College of Homoeopathy University Saipura Sanganer Jaipur 302029 |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
10 11 12 ward no 36 Saipura Sanganer Jaipur Rajathan 302029 |
| Type of Sponsor |
Private medical college |
|
|
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 Sachin Kumar Yadav |
Dr Girendra Pal Homoeopathic Hospital And Research Centre |
Department of Materia medica Dr MPK Homoeopathic Medical college hospital and research centre Plot no 10,11,12 ward 36 Saipura Sanganer
Jaipur
RAJASTHAN |
7877076255
ysachin7877@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Homoeopathy University Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guajacum Officinale |
All the patients having Symptoms of Arthralgia will be prescribed homoeopathic medicine Guajacum officinale.
The Homoeopathic medicine shall be given orally in any potency 30 CH, 200 CH,1M, and
10M as per the susceptibility of the patient and Hahnemannian guidelines of Organon of medicine in the form of globules number 40. Dose and repetition as per need of the case reassessment at the end of 3 month. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
patient with signs and symptoms suggestive of arthralgia based on clinical history and examination
As per Signs and Symptoms Patients with 3-4 Confirmatory signs and Symptoms given below shall be enrolled for the study
(joint pain or tenderness
redness warmth or swelling
reduced mobility
stiffness
tingling or other unusual sensation
numbness
burning feeling itching)
patient taking other modes of treatment and ready to stop their treatment
patient giving consent for study |
|
| ExclusionCriteria |
| Details |
Cases require emergency or surgical treatment
pregnant and lactating women will not be included
immuno compromised patients such as those suffering from HIV Hepatitis B C etc
cases with Multi Systemic illness and advanced pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of GUAJACUM OFFICINALE through evaluation of Pre and post NRS scores in the cases of Arthralgia |
Pre-scores will be taken at the baseline of treatment, and post score will be assessed at the end of 12 weeks using NRS scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to ascertain clinically proven symptoms of GUAJACUM OFFICINALE if any |
12 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/04/2025 |
| 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="0"
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 prospective, open-label, interventional, single-arm, and unicentric to assess the effectiveness of GUAJACUM OFFICINALE in the cases of Arthralgia. This study will evaluate the extent of improvement in joint pain using NRS Scale as an Assessment scale. The primary outcome will be according to the scores obtained (pre- and post-treatment) from the NRS score. The secondary outcome is to ascertain clinically proven symptoms of GUAJACUM OFFICINLALE, if any.
NULL HYPOTHESIS(H0)- there is no significant improvement assessed through pre and post-NRS scores in the cases of Arthralgia by Prescribing GUAJACUM OFFICINALE
ALTERNATE HYPOTHESIS(H1)- there is significant improvement assessed through pre and post-NRS scores in the cases of Arthralgia by Prescribing GUAJACUM OFFICINALE |