IRCT | The effect of davayebalgham capsule (a Persian medicine product) and acupuncture on blood sugar and lipid profile of type 2 diabetic patients (a randomized clinical study)

Protocol summary

Study aim: The effect of davayebalgham capsule and acupuncture on blood sugar and lipid profile of type ۲ diabetic patients
Design: A clinical trial with a control group, with parallel groups, single-blind, randomized, phase 3 on 105 patients. randomization with blocks of three is used by statistical software (SPSS).
Settings and conduct: Sampling will be done among the patients referred to the clinics affiliated with Tabriz University of Medical Sciences. After referring the candidates, a complete history is taken from them and the entry and exit criteria are evaluated. If they agree to participate in the project, the candidates will be randomly divided into three groups. Group one: herbal medicine, group two: placebo, and group three: will undergo acupuncture. Then the studied variables are recorded at the beginning of entering the design. At the beginning and end of 12 weeks, biochemical parameters are measured and recorded through a blood test after at least 12 hours of fasting by taking 8 cc of blood and other variables. In order to perform acupuncture, stimulation of st40, sp6, Li11, sj5, st25, Lu7, du20, ren4, ren17, and ren12 points will be made for 20 minutes with a size of 25 x 40. (once a week for 12 weeks)
Participants/Inclusion and exclusion criteria: Patients with type 2 diabetes without specific underlying disease in the age range of 20 to 65 years
Intervention groups: 1- davayebalgham product receiving group 2- Placebo, davayebalgham product receiving group 3- Acupuncture receiving group
Main outcome variables: Fasting blood sugar؛ Cholesterol؛ Triglycerides

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20220502054721N1

Registration date: 2022-10-22, 1401/07/30

Registration timing: registered_while_recruiting

Last update: 2022-10-22, 1401/07/30

Update count: 0
Registration date: 2022-10-22, 1401/07/30

Registrant information: Name

maryam rahimzade

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 8897 4535

Email address

m-rahimzade@razi.tums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2022-07-23, 1401/05/01
Expected recruitment end date: 2023-03-20, 1401/12/29
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effect of davayebalgham capsule (a Persian medicine product) and acupuncture on blood sugar and lipid profile of type 2 diabetic patients (a randomized clinical study)

Public title: The effect of davayebalgham capsule and acupuncture on type 2 diabetic patients
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Type 2 Diabetes patients Taking oral hypoglycemic drugs Age 20-65 years Satisfaction to enter the plan HbA۱C < %۹

Exclusion criteria:

Having serious gastrointestinal diseases including active stomach ulcers and gastrointestinal bleeding History of diabetic ketoacidosis, non-ketone hyperosmolar diabetic coma, severe infection or surgery in the previous month Kidney failure, liver dysfunction, cancers, cysts or breast mass, metabolic diseases Having a psychological illness Consumption of alcohol, drugs or psychotropic substances Uncontrolled hypertension (blood pressure greater than or equal to 100/160 mm Hg) History of myocardial infarction Taking anticoagulants (warfarin and Plavix ...) Insulin therapy over the past three months Continued use of herbs or other herbal medicines Fasting blood sugar above 180 Pregnancy, breastfeeding Having allergies to any of the plants
Age: From 20 years old to 65 years old
Gender: Both

Phase

3

Groups that have been masked

Participant

Sample size

Target sample size: 105

Randomization (investigator's opinion)

Randomized

Randomization description

Participants are divided into three groups in a random triple block (by SPSS software). They receive a group of herbal medicine, a group placebo of herbal medicine, and a group of acupuncture. After consenting to participate in the plan, people are randomly placed in one of the mentioned groups.

Blinding (investigator's opinion)

Single blinded

Blinding description

Patients are unaware that they are in the herbal intervention or placebo group.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Tehran University of Medical Sciences

Street address

No. 27، North Sarparsat Street، at the beginning of West Taleghani Street، Palestine Square

City

Tehran

Province

Tehran

Postal code

1416663361
Approval date: 2022-02-21, 1400/12/02
Ethics committee reference number: IR.TUMS.MEDICINE.REC.1400.1379

Health conditions studied

1

Description of health condition studied: Type 2 diabetes
ICD-10 code: E11
ICD-10 code description: Type 2 diabetes mellitus

Primary outcomes

1

Description: Fasting blood sugar
Timepoint: The beginning of the study, 3 months later
Method of measurement: laboratory kit

2

Description: Blood cholesterol
Timepoint: The beginning of the study, 3 months later
Method of measurement: Laboratory kit (blood test)

3

Description: Blood triglycerides
Timepoint: The beginning of the study, 3 months later
Method of measurement: Laboratory kit (blood test)

Secondary outcomes

1

Description: HbA۱C
Timepoint: The beginning of the study, 3 months later
Method of measurement: Laboratory kit (blood test)

Intervention groups

1

Description: Intervention group: Davaebalgham product. After the raw materials of this formulation including mastic gum, Trachyspermum ammi (L.) Sprague, Nigella sativa L and Zataria multiflora Boiss were obtained from the market of medicinal plants, a sample of plants was identified and A herbarium code is assigned to each sample. The quality control of the raw materials was done and the plants were ground and mixed with equal proportions of the powders of four plants. The mixed powder of four plants is formulated in the form of 500 mg hard gelatin capsules, so that each patient will receive 2.5 grams of the mixed plant powder in the form of medicinal capsules. For this purpose, each participant will receive the desired dose in 6 capsules of 500 mg (2 after breakfast, 2 after lunch and 2 after dinner) for 12 weeks.
Category: Treatment - Drugs

2

Description: Control group: Davaebalgham placebo.Placebo capsules will be filled with avicel and toast powder, and in order to match the color and smell of the content inside the capsules, edible colors and a very small percentage of essential oil will be used. Standardization of the product will be done by determining the amount of thymol by gas chromatography-mass spectrometry and determining the amount of total phenol.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Asadabadi Hospital

Full name of responsible person

Maryam Rahimzade

Street address

Bahar Street

City

Tabriz

Province

East Azarbaijan

Postal code

5169664343

Phone

+98 41 3384 2624

Email

rahimzademaryam2@gmail.com

1

Sponsor: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Akbar Fotuhi

Street address

Tehran University of Medical Sciences, Enghelab Street

City

Tehran

Province

Tehran

Postal code

1417613151

Phone

+98 21 8897 8745

Email

info@tpcf.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Tehran University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Maryam Rahimzade

Position

Assistant

Latest degree

Medical doctor

Other areas of specialty/work

Traditional Medicine

Street address

Ahmadiye Building, No. 27, North Sarparast Ave, Western Taleghani Ave, Felestin Square, Tehran Town

City

Tehran

Province

Tehran

Postal code

1416663361

Phone

+98 21 8897 4535

Fax

Email

m-rahimzade@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Amir Hooman Kazemi

Position

professor

Latest degree

Subspecialist

Other areas of specialty/work

Traditional Medicine

Street address

Ahmadiye Building, No. 27, North Sarparast Ave, Western Taleghani Ave, Felestin Square, Tehran Town

City

Tehran

Province

Tehran

Postal code

1416663361

Phone

+98 21 8897 4535

Fax

Email

amirhoomank@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Maryam Rahimzade

Position

Assistant

Latest degree

Medical doctor

Other areas of specialty/work

Traditional Medicine

Street address

Ahmadiye Building, No. 27, North Sarparast Ave, Western Taleghani Ave, Felestin Square, Tehran Town

City

Tehran

Province

Tehran

Postal code

1416663361

Phone

+98 21 8897 4535

Fax

Email

m-rahimzade@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Not applicable
Informed Consent Form: No - There is not a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Not applicable
Data Dictionary: Not applicable
Title and more details about the data/document: The collected data are published in the form of an article after analysis.
When the data will become available and for how long: After publishing the results
To whom data/document is available: Everyone (depending on magazine policies)
Under which criteria data/document could be used: The published study will be public
From where data/document is obtainable: The journal in which the article was published Author's Email: maryam rahimzade m-rahimzade@razi.tums.ac.ir
What processes are involved for a request to access data/document: After sending the email to the responsible author, the email will be answered within one month at most.
Comments

The effect of davayebalgham capsule (a Persian medicine product) and acupuncture on blood sugar and lipid profile of type 2 diabetic patients (a randomized clinical study)