Evaluation of the possible protective effect of Curmeric on the clinical evolution of patients in the post-acute and chronic period of Chikungunya disease

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of the possible protective effect of Curmeric on the clinical evolution of patients hospitalized at the IPK and in the post-acute and chronic period of Chikungunya disease

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Cuban Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Trials notification

Regulatory instance:

National Institute of Hygiene, Epidemiology and Microbiology (INHEM)

Notification date :

02/12/2025

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Beatriz

Last name:

Sierra Vazquez

Medical Specialty :

Second degree specialist in Immunology

Affiliation:

“Pedro Kouri” Institute of Tropical Medicine (IPK)

Postal address:

Autopista Novia del Mediodia, Km 6 1/2. La Lisa

City:

Havana

País:

Cuba

Zip Code:

11400

Telephone:

+53-52741140

Email address:

siebet@ipk.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

08/12/2025

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Acute, post-acute and chronic phases of chikungunya

Intervention(s):

Group I Curmeric (Experimental): Patients with no history of Curmeric use: 4 mL (1 teaspoon) three times a day after meals. Patients with a history of Curmeric use for more than 1 month: 4 mL (1 teaspoon) twice a day after meals. Patients admitted in the acute stage will receive treatment for 30 days, and those admitted in the subacute and chronic stages for 90 days. Patients who progress from the acute to the subacute and chronic stages will receive treatment for 90 days. Group II Standard therapy (Control): Conventional therapy according to the Cuban Protocol for the clinical management of CHIKV infection (Management and Research Protocol for Patients with Chikungunya). Patients admitted in the acute stage will receive treatment for 30 days, and those admitted in the subacute and chronic stages for 90 days. Patients who progress from the acute to the subacute and chronic stages will receive treatment for 90 days.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Symptoms (Type of symptom (Joint pain, Visible swelling in joints, Redness and warmth of joints, Muscle pain, Neuralgia with pain along the limb, Headaches, Nausea, General malaise, Fatigue, Rash, Bleeding, Diarrhea, Conjunctivitis); Symptom intensity (Measurement according to the VAS visual analog scale representing pain intensity where: a value less than 4 means mild or mild-moderate pain, a value between 4 and 6 implies the presence of moderate-severe pain, and a value greater than 6 implies the presence of very intense pain). Measurement time: At baseline, day 30, day 60 and day 90

Key secondary outcomes:

Adverse Events-AE (Occurrence of any AE (Yes, No); Description of the AE (Name of the adverse event/treatment); Duration of the AE (start and stop dates of the event) Intensity of the AE (mild, moderate, and severe); Severity (yes/no) yes: Patient death, Life-threatening condition, Hospitalization or prolongation of an existing hospitalization, Resulting in significant or persistent disability/impairment, Resulting in birth defect or congenital anomaly, Other events that may require any medical or surgical intervention to prevent any of the aforementioned conditions.) no: Not applicable. Measurement time: day 30, day 60, and day 90). Measurement time: day 30, day 60, and day 90

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

Inclusion criteria:

1. Patients aged 19 and over admitted to the IPK with a clinical diagnosis of Chikungunya disease. 2. Patients who provide their informed consent.

Exclusion criteria:

1. Patients with a history of allergy to turmeric or its derivatives 2. Pregnant or breastfeeding women 3. Patients with bleeding disorders or blood dyscrasias 4. Diseases of the biliary tract, chronic liver disease, hematological malignancies, and chronic rheumatological conditions 5. Terminal illness

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

150

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Beatriz

Last Name:

Sierra Vazquez

Specialty:

Second degree specialist in Immunology

Affiliation:

“Pedro Kouri” Institute of Tropical Medicine (IPK)

Postal Address:

Autopista Novia del Mediodia, Km 6 1/2. La Lisa

City:

Havana

País:

Cuba

Zip Code:

11400

Telephone:

+53-52741140

Email :

siebet@ipk.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Beatriz

Last Name:

Sierra Vazquez

Specialty:

Second degree specialist in Immunology

Affiliation:

“Pedro Kouri” Institute of Tropical Medicine (IPK)

Postal Address:

Autopista Novia del Mediodia, Km 6 1/2. La Lisa

City:

Havana

País:

Cuba

Zip Code:

11400

Telephone:

+53-52741140

Email :

siebet@ipk.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

“Pedro Kouri” Institute of Tropical Medicine (IPK)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

25/11/2025

Postal address of Ethic Committee :

Autopista Novia del Mediodia, Km 6 1/2. La Lisa. ZC: 11400, Havana, Cuba

Telephone:

+53-72553160

Correo electrónico:

daniel@ipk.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

06/04/2026

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000466

Date of Registration in Primary Registry:

04/12/2025

Record Verification Date:

2025/12/04

Next update date:

2026/12/04

Link to the spanish version:

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Evaluation of the possible protective effect of Curmeric on the clinical evolution of patients in the post-acute and chronic period of Chikungunya disease

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