Moringa in Diabetes

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 effect and safety of combined Moringa / Metformin treatment versus metformin in patients with type 2 diabetes mellitus. Exploratory study.

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Research Center for Protein Plants and Bionatural Products

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:

Ileydis

Last name:

Iglesias Marichal

Medical Specialty :

Second Degree Specialist in Endocrinology

Affiliation:

National Institute of Endocrinology and Metabolic Diseases

Postal address:

Zapata Street and D, Vedado

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78300534

+53-78310084

Email address:

ileydis@infomed.sld.cu [1]

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:

Havana, Diabetic Care Center of the Institute of Endocrinology, Marelys Llanes Quesada Ph, Second Degree Specialist in Endocrinology

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

15/11/2021

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:

Diabetes mellitus type 2

Health condition(s) code:

Diabetes Mellitus, Type 2

Diabetes Mellitus

Glucose Metabolism Disorders

Metabolic Diseases

Nutritional and Metabolic Diseases

Endocrine System Diseases

Intervention(s):

Group I Moringa (Experimental): Moringa oleifera 6 capsules of Moringa powder 100% (400 mg) daily by oral route + Metformin hydrochloride 4 tablets USP 500mg daily by oral route during 4 months. Group II Metformin (Control): Metformin hydrochloride 4 USP 500mg tablets daily by oral route during 4 months. In addition, non-pharmacological treatment will be indicated, which will include lifestyle changes (physical activity and nutritional guidelines).

Intervention code:

Moringa oleifera

Metformin

Capsules

Tablets

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):

Variation of glycosylated hemoglobin values (difference of the baseline Hb1Ac value with respect to the final value). Measurement time: At baseline and, at 4 months.

Key secondary outcomes:

Clinical and biochemical variables 1. Glycemic profile-PG (Laboratory values). Measurement time: At baseline and, 4 months. 2. Modifications in the treatment of the daily dose of Metformin hydrochloride USP 500mg (Difference: Starting dose - Dose after change (number of tablets), time of change). Measurement time: Up to 4 months. Safety: 1. Episodes of hypoglycemia. Measurement time: Up to 4 months 2. Episodes of hypotension. Measurement time: Up to 4 months 3. Adverse events (Occurrence of any AE (Yes, No), Type of AE (Name of the AE, Severity (Serious, Non-serious), Intensity (Mild, Moderate, Severe), Duration (It will be recorded by the start and end dates of the AE), Causation relationship (Very probable/Certain, Probable, Possible, Unlikely, Unrelated, Not evaluable/not classifiable), Attitude towards treatment (No changes, Temporary interruption, Definitive interruption of the treatment under study), Result of the AE (Recovered, Improved, Persists, Sequelae, Death due to AE, Unknown), Batch with which the EA is presented (The batch identification of the drug causing the AE will be collected). Measurement time: Up to 4 months.

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:

75 years

Inclusion criteria:

1. Patients who meet the diagnostic criteria. 2. Adults 19-75 years 3. Initial HbA1c ≥7% ≤ 9% 4. Patients who have given their informed consent to participate in the study.

Exclusion criteria:

1. Patients who, before starting the study, present elevations of: glutamic oxaloacetic transaminase, glutamic pyruvic transaminase, total bilirubin, or alkaline phosphatase greater than or equal to 2.5 times the institutional upper normal limit. 2. Patients who, before starting the study, present a glomerular filtration rate of less than 60 ml / min according to the Cockcroft-Gault formula. 3. Patients treated with steroids by any route of administration 3 months before starting the study. 4. Patients with unstable ischemic heart disease or decompensated arterial hypertension. 5. Patients being treated with insulin or another hypoglycemic agent other than Metformin. 6. Patients with decompensated diabetic complications that require treatment. 7. Anticoagulated patients or those with blood dyscrasias and hemolytic anemia. 8. Pregnant and postpartum and breastfeeding patients.

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:

Target sample size:

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:

Concepcion

Last Name:

Campa Huerga

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Research Center for Protein Plants and Bionatural Products

Postal Address:

Ave 212 No 3112 between 31 and 37. La Coronela. Lisa

City:

Havana

País:

Cuba

Zip Code:

1711

Telephone:

+53-52850016

Email :

ccampa@bionaturasm.cu [2]

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:

Ileydis

Last Name:

Iglesias Marichal

Specialty:

Second Degree Specialist in Endocrinology

Affiliation:

National Institute of Endocrinology and Metabolic Diseases

Postal Address:

Zapata Street and D, Vedado

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78300534 , +53-78310080

Email :

ileydis@infomed.sld.cu [1]

Research Ethics Committees

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

Name of Research Ethics Committees:

Institute of Endocrinology and Metabolic Diseases

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

14/10/2021

Postal address of Ethic Committee :

Zapata and D, Vedado, Plaza de la Revolucion, Havana ZC 10400. Cuba

Telephone:

+53-78300534

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/06/2022

Date of available results:

30/12/2022

Date of first publication:

30/01/2023

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:

RPCEC00000395

Date of Registration in Primary Registry:

02/11/2021

Record Verification Date:

2021/11/03

Next update date:

2022/11/03

Link to the spanish version:

Click here [3]