| CTRI Number |
CTRI/2025/12/099601 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
20/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing individualized homoeopathic Medicine and Urtica Urens for managing high uric acid level in adults |
|
Scientific Title of Study
|
A comparative evaluation of the efficacy of individualized homeopathic medicines and urtica urens in treatment of hyperuricemia in adults: an open-label, parallel-arm, intervention 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 Pranab Pal |
| Designation |
Post Graduate Trainee |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica(1st Floor)
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Sailen manna Sarani( Drainage Canal Road),Doomurjala, Howrah.711104
Haora WEST BENGAL 711104 India |
| Phone |
7047188306 |
| Fax |
|
| Email |
dr.pranabpal6385@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrTrishita Basu |
| Designation |
Reader, Department Of Homoeopathic Materia Medica |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica( 1st Floor),
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. Sailen manna Sarani( Drainage Canal Road),Doomurjala, Howrah.711104
Haora WEST BENGAL 711104 India |
| Phone |
8334941727 |
| Fax |
|
| Email |
drtrishita85@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Trishita Basu |
| Designation |
Reader, Department Of Homoeopathic Materia Medica |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica(1st Floor)
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Sailen manna Sarani( Drainage Canal Road),Doomurjala, Howrah.711104
Haora WEST BENGAL 711104 India |
| Phone |
8334941727 |
| Fax |
|
| Email |
drtrishita85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College and Hospital.
Sailen Manna sarani, Dumurjala , Howrah, 711104 |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. |
| Address |
Sailen Manna Sarani( Drainage Canal Road),Doomurjala, Howrah-711104 |
| Type of Sponsor |
Government 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 Pranab Pal |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. |
Department Of Practice of Medicine ,OPD No. 1,2,3,4,5,7,9,10, PG OPD Room No.11,Emergency. Haora WEST BENGAL |
7047188306
dr.pranabpal6385@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E799||Disorder of purine and pyrimidinemetabolism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualized homoeopathic medicines. |
Intervention is planned as administering individualised homoeopathic medicines in centesimal potencies(CH), according to the symptom’s totality of the patients. In centesimal scale, each dose shall consist of 4-6 globules (no.20) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach in early morning. doses and repetition of medicine depending upon the individual requirement of the cases. Medicine will be dispensed from dispensary of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 1 hour of taking medicine and will be procured from a good manufacturing Practice (GMP) certified firm. Patient advises to taking normal diet. |
| Intervention |
Urtica urens in centesimal potency( 6C,30C,200C) |
This arm will receive Urtica urens in centesimal potency, , each dose shall consist of 4-6 globules (no.20) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach in early morning. doses and repetition of medicine depending upon the individual requirement of the cases. Medicine will be dispensed from dispensary of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 1 hour of taking medicine and will be procured from a good manufacturing Practice (GMP) certified firm. Patient will taking normal diet. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient reporting with serum uric acid more than 6.0 mg per dl in women and more than 7.0 mg per dl in men.
2.Patient is not taking any medication for same complaints for at least 1 months.
3.Patients who are not undergo Homoeopathic treatment for last 4 weeks
|
|
| ExclusionCriteria |
| Details |
1.Diagnosed case of unstable mental or psychiatric illness.
2.Secondary causes of Hyperuricemia with advanced pathology (Like Leukaemia, Lymphoma, Tumour lysis syndrome etc.)
3.Pregnant and lactating mothers
4.Substance abuse and/or dependence
5.Self-reported cases of immune compromised state.
6.Patient taking any medication for same complaints for at least 1 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the comparative effectiveness of individualized homoeopathic medicines and Urtica Urens in the reduction of serum uric acid level. |
Baseline to the end of 3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the improvement of overall quality of life by using EQ-5D-5L Questionnaire.
2.To determine the most frequently indicated homoeopathic medicine and their indications in the treatment of hyperuricemia.
3.To find out the socio-demographic characteristic of patients suffering from Hyperuricemia patients in Mahesh Bhattacharyya homoeopathic medical college and hospital at Howrah, West Bengal, OPD and IPD. |
Baseline to the end of 3 months and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="92" Sample Size from India="92"
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)
|
02/01/2026 |
| 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="6" 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 investigates the comparative effectiveness of individualized homoeopathic medicines and Urtica urens in managing hyperuricemia in adults through an open-label, parallel-arm intervention design. Hyperuricemia is defined as elevated serum uric acid caused by either increased production or reduced renal excretion, predisposing patients to gout, nephrolithiasis and cardiovascular risk. Serum uric acid higher than 7.0 mg per dL, in men and higher than 6.0 mg per dL, in women is used as the diagnostic benchmark for enrolment. The study aims to assess reduction in uric acid levels and improvement in overall quality of life using the EQ-5D-5L scale. Participants are randomized into two groups: one receiving potentized Urtica urens and the other receiving individualized homoeopathic medicines selected on the basis of totality of symptoms.
Adults aged 18–70 years of both sexes are included, provided they have hyperuricemia within the specified uric acid thresholds, are not under any treatment for the same condition for at least one month, and have not taken homoeopathic medicines in the previous four weeks. Exclusion criteria include pregnancy and lactation, unstable psychiatric illness, immune-compromised states, substance abuse, secondary hyperuricemia associated with advanced pathology such as leukemia or tumor lysis syndrome, and patients taking medications for hyperuricemia within the past month. Participants are followed every four weeks for six months, and serum uric acid evaluations are conducted at baseline, at the third and sixth follow-ups. The comparative outcomes are statistically analyzed to determine which approach offers greater reduction in serum uric acid and better improvement in health-related quality of life. |