| CTRI Number |
CTRI/2025/09/094903 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare between Benzoic acid and Homoeopathic medicines in the treatment of Hyperuricemia. |
|
Scientific Title of Study
|
Comparative Evaluation of Individualised Homoeopathic Medicines and Benzoic acid in Management of cases of Hyperuricemia- A Prospective Double Arm Study. |
| 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 Ritika Dhamija |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical college and Hospital |
| Address |
B 17 Department of Practice of Medicine basement Bakson Homoeopathic Medical College and Hospital 36 B knowledge park phase 1 greater noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
08851568843 |
| Fax |
|
| Email |
ritikadhamija99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaya Goswami |
| Designation |
Guide |
| Affiliation |
Bakson Homoeopathic Medical college and Hospital |
| Address |
B 17 Department of Practice of Medicine basement Bakson Homoeopathic Medical College and Hospital 36 B knowledge park phase 1 greater noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
08851568843 |
| Fax |
|
| Email |
vijaya84goswami@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Mathur |
| Designation |
HOD |
| Affiliation |
Bakson Homoeopathic Medical college and Hospital |
| Address |
B 17 Department of Practice of Medicine basement Bakson Homoeopathic Medical College and Hospital 36 B knowledge park phase 1 greater noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
08851568843 |
| Fax |
|
| Email |
drakshaymathur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital
Ground Floor
Principal Office Room No G 22
36 B knowledge park phase 1 greater noida Uttar pradesh 201306 |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Bakson Homoeopathic Medical College and Hospital Ground Floor Principal Office Room No G 22 36 B knowledge park phase 1 greater noida Uttar pradesh 201306 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR RITIKA DHAMIJA |
Bakson Homoeopathic Medical College OPD |
OPD
Room No 1
Ground floor
Bakson Homoeopathic Medical College and Hospital
36 B knowledge park phase 1 greater noida Uttar Pradesh 201306
Gautam Buddha Nagar
UTTAR PRADESH |
08851568843
ritikadhamija99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bakson Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E790||Hyperuricemia without signs of inflammatory arthritis and tophaceous disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Benzoic acid |
Oral Route of Administration
30 pill size
centesimal potencies in ascending order of potency starting with 30 potency.
First dose after case taking.
repetition according to follow up. |
| Comparator Agent |
Individualised Homoeopathic medicines |
Oral Route of Administration 30 pill size centesimal potencies in ascending order of potency starting with 30 potency. First dose after case taking. repetition according to follow up. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Participants with SUA levels in males more than 7.0g/dl and females with SUA levels more than 6.0g/dl
Participants may or may not be present with symptoms like joint pains, stiffness etc.
Participants willing to give consent |
|
| ExclusionCriteria |
| Details |
Participants with unstable mental or psychiatric diseases, uncontrolled or severe systemic illness, autoimmune diseases, immunocompromised diseases.
Participants with joint deformities or chronic tophaceous gout (as these cases represent irreversible pathology)
Participants with chronic kidney disease ( stage 3 or higher) or serum creatinine more than 1.5mg/dl
Pregnant and lactating females
Participants with renal complications ( SUA levels more than 13mg/dl) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare changes of pain levels in individualised group and benzoic acid group using VAS scale |
total 16 months study
enrollment period of 6 months
follow up of 6 months
data analysis 2 months
report writing 2 months
Vas scale to be used at baseline, 4 weeks upto 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare changes in symptomatology of hyperuricemia- frequency, intensity, stiffness and mobility in individualised group and benzoic acid group |
total 16 months study
enrollment period of 6 months
follow up of 6 months
data analysis 2 months
report writing 2 months |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
26/09/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| 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
|
Comparing the role of Benzoic acid with individualised Homoeopathic medicine in managing the symptoms of hyperuricemia in adults in which Benzoic acid will be given to group A and individualised Homoeopathic medicine will be given to group B and each group will have 34 participants. VAS scale will be used to compare pain levels and serum uric acid levels will be tested at baseline, after 1 month upto 6 months |