Rectal ozone therapy in patients with joint symptoms following the acute phase of Chikungunya.

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.

Acronym of Public Title:

OZOR -CHK

Scientific title:

Evaluation of the effects, safety, and tolerability of rectal ozone therapy in patients with joint symptoms following the acute phase of Chikungunya

Acronym of Scientific Title:

OZOR -CHK

Secondary indentifying numbers:

OZOR-CHK-01

Issuing authority of the secondary identifying numbers:

National Center for Scientific Research (CNIC)

Source(s) of monetary or material support:

National Center for Scientific Research (CNIC)

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:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

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

First name:

Joaquina

Last name:

Gomez Peire

Medical Specialty :

First degree specialist in Natural and Traditional Medicine

Affiliation:

Frank Pais International Orthopedic Complex

Postal address:

Ave 51 #19603 e/ 202 y 196, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

17100

Telephone:

+53-52533670

Email address:

peire@infomed.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:

07/01/2026

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:

Arthritis following the acute phase of Chikungunya

Intervention(s):

Ozone Therapy Group (Experimental): Medical ozone in gaseous form will be administered rectally for 4 weeks, daily from Monday to Friday (20 sessions), using the ascending stepwise method as shown below. Week 1: Concentration of 20 μg/mL in 150 mL of volume; Week 2: Concentration of 25 μg/mL in 150 mL of volume; Week 3: Concentration of 30 μg/mL in 200 mL of volume; and Week 4: Concentration of 25 μg/mL in 200 mL of volume.

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):

Joint pain (Using VAS (Visual Analog Scale) where 0-No pain, 1–3 Mild pain, 4–6 Moderate pain, and 7–10 Severe pain). Measurement time: At baseline, and for 4 weeks, on a weekly basis

Key secondary outcomes:

1. Joint Function (Measured using the HAQ (Health Assessment Questionnaire), which has values between 0 (no disability) and 3 (maximum disability)). Measurement period: At baseline, and for 4 weeks, on a weekly basis. 2. Disease Activity Score (DAS) (<2.6 disease remission, 2.6–3.2 low disease activity, >3.2–5.1 moderate disease activity, >5.1 high disease activity). Measurement time: At baseline and end of treatment. 3. Redox status (The following values will be measured: MDA (Malonaldehyde Concentration), PP (Lipid Peroxidation Susceptibility), CAT (Catalase Enzyme Activity), GSH (Reduced Glutathione Concentration), SOD (Superoxide Dismutase Enzyme Activity), PAOP (Advanced Protein Oxidation Products Concentration), HOP (Total Organoperoxide Concentration)). Measurement time: At baseline and end of treatment. 4. Quality of life (Measured using the EQ-5D 3L Questionnaire, where 5 indicates the best quality of life, and 15 indicates the Worst quality of life). (Worse quality of life). Measurement time: At baseline and end of treatment. 5. Adverse Events- AE (The following will be measured: Incidence of AE in patients (Yes, No); Description of the AE (Symptoms and/or signs); Date and time of start and stop; Severity of the AE (According to CTCAE severity grades 1 to 5); Causality of the AE (Very likely, likely, possible, unlikely, unrelated); Management: (No treatment required; General measures; Emergency treatment; Hospital admission); Outcome of the AE (Recovered, improved, persists, sequelae, death); Attitude towards treatment: (No change, dose modification, discontinuation)). Measurement time: At the end of the 4 weeks of treatment. 6. Hematological parameters (For hematological toxicity, Hemoglobin, Red blood cell count, White blood cell count, and Platelet count will be measured; for Liver function, Alanine will be measured. Aspartate aminotransferase (ALT) and aspartate aminotransferase (AST) will be measured; for pancreatic function, blood glucose will be measured, and for renal function, creatinine will be measured. Measurement timing: At baseline and end of treatment. 7. Vital signs: These will be measured if clinically relevant changes occur compared to baseline values for the variables (weight, blood pressure, heart rate). Measurement timing: At baseline and for 4 weeks, on a weekly basis. 8. Tolerability (This will be measured using the TOL-AR-18 questionnaire, modified for rectal ozone therapy, taking into account the total number of reported events and specifying which of the 18 items was positive). Measurement timing: At baseline and for 4 weeks, on a weekly basis.

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:

90 years

Inclusion criteria:

1. Adults of any sex, older than 19 years until 90 years old. 2. Clinically confirmed diagnosis of Chikungunya. 3. Signed informed consent form agreeing to participate in the clinical trial. 4. Persistent joint pain (mild to moderate, as measured by the VAS) and swelling following Chikungunya.

Exclusion criteria:

1. Glucose-6-phosphate dehydrogenase deficiency (favism). 2. Anemia (Hb ≤ 10 g/L). 3. Pregnancy. 4. Thrombocytopenia. 5. Uncontrolled hypertension (SBP > 140 mmHg, DBP > 90 mmHg). 6. Hyperthyroidism. 7. Seizures. 8. Unstable heart disease. 9. Chronic diseases without evidence of beneficial use of ozone therapy. 10. Hypoglycemia. 11. Ozone allergy. 12. Alcoholism. 13. Cognitive impairment that prevents truthful answers. 14. Use of steroids or immunosuppressants. 15. Local inflammatory processes in the application area.

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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

1-2

Target sample size:

30

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:

Evelyn

Middle Name:

Anie

Last Name:

Gonzalez Pla

Specialty:

Second Degree Specialist in Natural and Traditional Medicine

Affiliation:

National Center for Scientific Research (CNIC)

Postal Address:

Avenida 25 y 148, Reparto Cubanacan.

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72627022

Email :

evelyn.gonzalez@cnic.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:

Evelyn

Middle Name:

Anie

Last Name:

Gonzalez Pla

Specialty:

Second Degree Specialist in Natural and Traditional Medicine

Affiliation:

National Center for Scientific Research (CNIC)

Postal Address:

Avenida 25 y 148, Reparto Cubanacan

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-54172369

Email :

evelyn.gonzalez@cnic.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Frank Pais International Orthopedic Complex

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

17/11/2025

Postal address of Ethic Committee :

Ave 51 #19603 e/ 202 y 196, La Lisa, La Habana, ZC: 17100, Cuba

Telephone:

+53-52719055

Email:

direccionfp@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

27/03/2026

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:

RPCEC00000467

Date of Registration in Primary Registry:

08/12/2025

Record Verification Date:

2025/12/08

Next update date:

2026/12/08

Link to the spanish version:

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Rectal ozone therapy in patients with joint symptoms following the acute phase of Chikungunya.

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