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IRCT20220502054721N1 IRCT 2022-10-22 Tehran University of Medical Sciences The effect of davayebalgham capsule and acupuncture on type 2 diabetic patients 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) 2022-07-23 anticipated 105 Complete https://irct.ir/trial/63359 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 description: Patients are unaware that they are in the herbal intervention or placebo group. 3 Type 2 diabetes. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: The collected data are published in the form of an article after analysis. When: After publishing the results To whom: Everyone (depending on magazine policies) Conditions: The published study will be public Where to obtain: The journal in which the article was published Author's Email: maryam rahimzade m-rahimzade@razi.tums.ac.ir How to obtain: After sending the email to the responsible author, the email will be answered within one month at most. Comments:
public Maryam Rahimzade
Ahmadiye Building, No. 27, North Sarparast Ave, Western Taleghani Ave, Felestin Square, Tehran Town
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8897 4535 m-rahimzade@razi.tums.ac.ir Tehran University of Medical Sciences scientific Amir Hooman Kazemi
Ahmadiye Building, No. 27, North Sarparast Ave, Western Taleghani Ave, Felestin Square, Tehran Town
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8897 4535 amirhoomank@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Type 2 Diabetes patients Taking oral hypoglycemic drugs Age 20-65 years Satisfaction to enter the plan HbA۱C < %۹ 20 years 65 years Both 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 E11 Type 2 diabetes mellitus Treatment - Drugs Placebo 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. 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. Fasting blood sugar. Timepoint: The beginning of the study, 3 months later. Method of measurement: laboratory kit. Blood cholesterol. Timepoint: The beginning of the study, 3 months later. Method of measurement: Laboratory kit (blood test). Blood triglycerides. Timepoint: The beginning of the study, 3 months later. Method of measurement: Laboratory kit (blood test). HbA۱C. Timepoint: The beginning of the study, 3 months later. Method of measurement: Laboratory kit (blood test). Tehran University of Medical Sciences Approved 2022-02-21 Ethics committee of Tehran University of Medical Sciences No. 27، North Sarparsat Street، at the beginning of West Taleghani Street، Palestine Square Tehran Tehran Iran (Islamic Republic of)