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CTRI Number  CTRI/2024/12/077620 [Registered on: 03/12/2024] Trial Registered Prospectively
Last Modified On: 05/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homeopathic treatment of high uric acid levels in blood 
Scientific Title of Study   Efficacy of Individualized Homoeopathic Medicines in the Treatment of Hyperuricemia in Adults: A Double-Blind, Randomized, Placebo-Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1315-8872  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Washim Reza Molla 
Designation  Postgraduate Trainee 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Department of Materia Medica, OPD room no. PG2 (Materia Medica), 1 (Medicine), 12, Gobinda Khatick Road, Tangra Kolkata

Kolkata
WEST BENGAL
700046
India 
Phone  9903220428  
Fax    
Email  washimreza5005@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Saima Shamim 
Designation  Associate professor 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Department of Materia Medica, OPD room no. PG2 (Materia Medica), 1 (Medicine), 12, Gobinda Khatick Road, Tangra Kolkata

Kolkata
WEST BENGAL
700046
India 
Phone  7059526218  
Fax    
Email  drsaima_7@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Saima Shamim 
Designation  Associate professor 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Department of Materia Medica, OPD room no. PG2 (Materia Medica), 1 (Medicine), 12, Gobinda Khatick Road, Tangra Kolkata

Kolkata
WEST BENGAL
700046
India 
Phone  7059526218  
Fax    
Email  drsaima_7@yahoo.com  
 
Source of Monetary or Material Support  
D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra Kolkata 700046, West Bengal 
 
Primary Sponsor  
Name  D N De Homoeopathic Medical College and Hospital 
Address  12, Gobinda Khatick Road, Tangra Kolkata 700046, West Bengal 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Washim Reza Molla  D N De Homoeopathic Medical College and Hospital  Department of Materia Medica, OPD room no. PG2 (Materia Medica), 1 (Medicine), 12, Gobinda Khatick Road, Tangra Kolkata
Kolkata
WEST BENGAL 		 9903220428

washimreza5005@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of D N De Homoeopathic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Identical-looking placebos plus concomitant care  This group will be given a placebo that looks exactly like verum. Four cane sugar globules No. 40 moistened with 90 % v/v ethanol will make up each dose, which should be taken orally on an empty stomach and clean tongue. The quantity of dose and frequency of administration will be determined by the specific needs of each patient. The supplier of all other components will be a company accredited by Good Manufacturing Practices (GMP). The therapy lasted for three months. The medications and placebos will be repackaged in matching glass bottles, labelled with the name of the medication, its potency, and the code. The random number list will be used to determine how the medications are given. Concomitant care will be given to all enrolled patients. These guidelines include avoiding alcohol (especially beer), bacon, beef, lamb, veal, and organ meats; additionally, some fish and shellfish (such as tuna, herring, mussels, shrimp, lobster, and codfish), as well as red meat, poultry, oysters, seafood, cauliflower, mushrooms, spinach, beans, peas, fructose, and other foods, may raise the risk of hyperuricemia and gout. Conversely, a low-fructose diet and the use of dairy or soy products reduce the risk of hyperuricemia. Reminding the participants verbally over the phone once a week and during each follow-up visit will ensure that they follow the advice. Route of administration per oral, duration of therapy 3 months  
Intervention  Individualized homeopathic medicines in centesimal potencies plus concomitant care  Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Every dosage consists of 4 cane sugar globules no. 40 moistened with the prescribed medication (preserved in 90% v/v ethanol), which is to be taken orally on an empty stomach with a clean tongue. The dosage and frequency of administration depend on the specific needs of each case. Patients will be instructed to suck the globules rather than swallow them, and they will be forbidden from handling the globules or from eating, drinking, smoking, or brushing their teeth for 30 minutes after ingesting them. Every time, a single customized medication will be prescribed, taking into consideration the entirety of the patients presenting symptoms, the clinical history, constitutional characteristics, miasmatic expressions, and, when necessary, repertorization using HOMPATH/RADAR software. This will be done after consulting the Materia Medica and reaching a consensus among three homoeopaths. Every drug and other item will be purchased from a company that has earned Good Manufacturing Practice (GMP) certification. The therapy lasted for a period of three months. Concomitant care will be given to all enrolled patients. These guidelines include avoiding alcohol (especially beer), bacon, beef, lamb, veal, and organ meats; additionally, some fish and shellfish (such as tuna, herring, mussels, shrimp, lobster, and codfish), as well as red meat, poultry, oysters, seafood, cauliflower, mushrooms, spinach, beans, peas, fructose, and other foods, may raise the risk of hyperuricemia and gout. Conversely, a low-fructose diet and the use of dairy or soy products reduce the risk of hyperuricemia. Reminding the participants verbally over the phone once a week and during each follow-up visit will ensure that they follow the advice. Route of administration per oral, duration of therapy 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients aged between 18 and 65 years.
2. Patients of both sexes.
3. Pre-Diagnosed & newly diagnosed cases of hyperuricemia [ICD-10 -diagnosis code-E79.0] (serum uric acid level above 7 mg/dl in men and above 6 mg/dl for women) with or without gout.
4. Suspected cases of Hyperuricemia. (History of attack of Gout, Family history of gout, Recurrent uric acid nephrolithiasis, obesity, hypertension, Diabetes, etc.)
5. If the patients were already undergoing treatment for hyperuricemia will be enrolled into the study after a wash-out period of one month subject to fulfilment of the eligibility criteria.
6. Patients’ ability to understand Bengali and/or English or Hindi. 
 
ExclusionCriteria 
Details  1. Denying written informed consent.
2. Overt hyperuricemia (i.e. serum uric acid levels of more than 10 mg/dL)
3. Secondary gout, severe or advanced gout requiring surgical procedures or orthopedic corrections.
4. Unstable mental or psychiatric illness or other systemic diseases affecting the quality of life or any vital organ failure.
5. Currently receiving homoeopathic treatment for any chronic condition(s)
6. Self-reported immune-compromised state.
7. Pregnant and puerperal women, lactating mothers.
8. Already undergoing homoeopathic treatment for chronic disease within last 3 months.
9. Simultaneous participation in any other clinical trial.
10. Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool). 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Serum uric acid levels  At baseline, every month, up to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Hyperuricemia quality of life questionnaire (HUQoLQ)  At baseline, every month, up to 3 months 
The Short Form 36 (SF-36) questionnaire   At baseline, every month, up to 3 months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 2/ Phase 3 
Date of First Enrollment (India)   16/12/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [washimreza5005@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  		 Hyperuricemia is defined as an elevated serum uric acid level usually above 360 μmol/l (6 mg/dL) for women and 420 μmol/l (7.0 mg/dL) for men. In a review on population-based prevalence, hyperuricemia was placed at the 13th position among 21 Global Burden of Diseases (GBD).The majority of those who have this disorder won’t show any overt symptoms, but it’s unknown how long-term hyperuricemia may affect renal function, general morbidity, and cardiovascular health in general. Conventionally, allopurinol has only been used to treat hyperuricemia; however, The most well-known side effect of allopurinol in dermatology is its severe cutaneous adverse responses. Homoeopathy is the second largest widely accepted therapeutic system of Medicine, may offer a better alternative in prevention and treatment hyperuricemia HU. Despite the abundance of successfully treated examples of hyperuricemia and gout in homoeopathy literature, high quality research evidence is still limited. Although many good qualities clinical trial have been published under the name of hyperuricemia in Homoeopathy. But most of the randomized, placebo-controlled trial done at 1:1 ratio. So, this trial is nothing but another attempt to detect and prove the efficacy of IHMs in reducing the serum uric acid levels (SUA) by 2:1 Randomized ratio. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 64 adults who are suffering from  HU at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done using SUA levels [Primary outcomes], Questionnaire assessing impact of hyperuricemia on quality of life (HUQoLQ) score and SF -36 (Short Form-36) [Secondary outcomes] every month up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals. 
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