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IRCT20130911014630N10 IRCT 2022-05-13 Vice chancellor for research, Faculty of Pharmacy Evaluation of Local Effect of Cuttlebone Lipogel on Sub-Cutaneous Fat Accumulation Evaluation of Local Effect of Cuttlebone Lipogel on Sub-Cutaneous Fat Accumulation in women; A Randomized, Placebo-Controlled, Double-Blinded Study 2019-05-21 anticipated 30 Complete https://irct.ir/trial/35383 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Excel software was used for randomization. Using the Rand function in Excel software, random numbers are obtained and using these numbers, each person in the study is placed in drug or placebo group, Blinding description: In this Study, patients and Data Analyzer have no information about the product that it is drug or placebo. the products have given pre - determined cods and randomly assigned to the patients. N/A Sub-Cutaneous Fat Accumulation. Intervention 1: Intervention group: 15 individual received Cuttlebone Lipogel. At this stage, based on the recommended amounts of traditional medicine and taking into account the non-toxicity, the amount of Cuttlebone consumption per 100 grams of the gel base is 10 grams and the amount of lipogel consumption three times a day is about 5 grams for an area of 250cm2 (25 × 10 cm) from the person's abdomen will be considered. Duration of the intervention is 12 weeks. Intervention 2: Control group: 15 patients were randomly selected and received placebo for 12 weeks, 3 times a day. 5 grams of the gel applys on 250 cm2 of abdomonal area. The placebo contains all the ingredients of the main medicine, but the active ingredient of the sea floor has been removed. Yes - There is a plan to make this available What will be shared: Results from clinical trials When: 1400/12/10 To whom: Researchers working in academic institutions Conditions: Use of results is allowed only with the mention of the source and In order to expand the study Where to obtain: Fatemeh Akbari، 09128518809، f_akbari1987@yahoo.com How to obtain: At the request of the researcher, once the medicinal product has been registered, the documents will be sent to the applicant immediately. Comments: This plan will be at the disposal of the author for further studies until reaching the pharmaceutical product.
public Mohammad Azadbakht
18 KM Kazarabad Road, The Campus of Mazandaran University of Medical Sciences and health services
Sari Iran (Islamic Republic of) 48188-69378 +98 15 1214 4052 mazadbakht@mazums.ac.ir Mazandaran University of Medical Sciences scientific Fatemeh Akbari
Payambar Azam Medicinal Complex-Pharmacy College - Sari
Sari Iran (Islamic Republic of) - +98 912 851 8809 f_akbari1987@Yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) obese women referring to a specialist Age range 18 to 50 years patient has a disorder of subcutaneous fat accumulation patient has a personal dissatisfaction with the use of the product. 18 years 50 years Female People under 18 and over 50 pregnant women people with systemic diseases leading to obesity people taking certain obesity-causing drugs people who are allergic to plant and seafood products Treatment - Drugs Placebo Intervention group: 15 individual received Cuttlebone Lipogel. At this stage, based on the recommended amounts of traditional medicine and taking into account the non-toxicity, the amount of Cuttlebone consumption per 100 grams of the gel base is 10 grams and the amount of lipogel consumption three times a day is about 5 grams for an area of 250cm2 (25 × 10 cm) from the person's abdomen will be considered. Duration of the intervention is 12 weeks. Control group: 15 patients were randomly selected and received placebo for 12 weeks, 3 times a day. 5 grams of the gel applys on 250 cm2 of abdomonal area. The placebo contains all the ingredients of the main medicine, but the active ingredient of the sea floor has been removed Localized obesity or waist size. Timepoint: at baseline and after 12 week. Method of measurement: Tape meters. Waist-Hip Ratio. Timepoint: at baseline and after 12 week. Method of measurement: Tape meters. Blood serum lipid profile including Triglycerides, cholesterol and Low and high density lipoproteins. Timepoint: at baseline and after 12 week. Method of measurement: Blood test. Vice chancellor for research, Faculty of Pharmacy Approved 2019-06-17 Ethics Committee of Mazandaran University of Medical Sciences Prophet Mohammad Medical Sciences Complex.Farahabad Street Sari Mazandaran Iran (Islamic Republic of)