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IRCT20170311033004N3 IRCT 2022-02-01 Iranian academic center for education culture and research Effects of alkaloids of harmala seeds on depression Evaluation of adjunctive therapy of seeds alkaloids of Peganum harmala in the treatment of mild to moderate depression 2022-04-03 anticipated 68 Complete https://irct.ir/trial/61563 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed through block randomization (block of four). In Excel, we would arrange the Treatment and Control values systematically and then add a column with a block number. The third column would be our random numbers. Here is what it would look like. Then, we sort the numbers, by block and by random number within block, Blinding description: Blinding and randomization will be carried out by an independent person unrelated to the study, while the investigator will administrate capsules and will assess the patients. Capsules will be packed and numbered serially using numbers generated by random number tables. They are the same in appearance, size, and color. 2 Depression. Intervention 1: Intervention group: harmala alkaloids: Extraction is performed through routine methods for alkaloids extraction. Then a semi-automatic capsule filler was used to fill the harmaline capsules, prepared in an opaque plastic container. Each container consists of 42 hard gelatin capsules for six weeks of intake. Patients received either harmaline powder capsules (10 mg) per day, standardized to reference harmaline. Each capsule contained an equivalent 10 mg harmaline powder. All capsules were manufactured and packed in the Institute of Medicinal Plants (IMP), Alborz, Iran. Intervention 2: Control group: placebo: Placebo capsules, with the exact size, color, and appearance, were filled with fried bread (Roshd Co. Yazd, Iran). A semi-automatic capsule filler was used to fill the placebo capsules. Each container consists of 42 hard gelatin capsules for six weeks of intake. All capsules were manufactured and packed in the Institute of Medicinal Plants (IMP), Alborz, Iran. Yes - There is a plan to make this available What will be shared: Demographic data, the total score of questionnaires, and laboratory test's results When: Immediately after publishing the data To whom: Researchers at medical universities Conditions: Scores of the questionnaires and laboratory data are available for reviews and meta-analyses. Where to obtain: Dr Ali Razmi assistant professor of the institute of medicinal plants is responsible for sharing data email: a.razmi@yahoo.com Tel: 00989123945632 How to obtain: Applicants could send their requests through email. The data will be available after identification. Comments:
public Ali Razmi
Kamalshahr, Jahad daneshgahi research complex
Kamalshahr Iran (Islamic Republic of) 1689734337 +98 26 3476 4010 arazmi@alumnus.tums.ac.ir Iranian academic center for education culture and research scientific Ali Razmi
Kamalshahr, Jahad daneshgahi research complex
Kamalshahr Iran (Islamic Republic of) 1689734337 +98 26 3476 4010 arazmi@alumnus.tums.ac.ir Iranian academic center for education culture and research Iran (Islamic Republic of) ability to read, understating and sign the informed consent form and the study procedures male or female aged 18–65 years without any previous diagnosis of other mental disorders such as bipolar disorder, psychosis, primary anxiety disorder, and substance abuse or dependence disorder reporting the Hamilton Depression Rating Score (HAMD) score above 14 agreed to use suitable family planning methods during the study and three months afterward non-smoking not being pregnant under only SSRIs antidepressant regimen 18 years 65 years Both they have a current diagnosis of other mental disorders including bipolar disorder, psychosis, primary anxiety disorder, and substance abuse or dependence disorder pregnancy and breastfeeding taking antidepressant except for SSRIs, mood stabilizer, or antipsychotic drug chemotherapy or other medications known to produce mood changes sensitivity to harmala alkaloids emerging serious adverse effects with the alkaloids F33.1 Major depressive disorder, recurrent, moderate Treatment - Drugs Treatment - Drugs Intervention group: harmala alkaloids: Extraction is performed through routine methods for alkaloids extraction. Then a semi-automatic capsule filler was used to fill the harmaline capsules, prepared in an opaque plastic container. Each container consists of 42 hard gelatin capsules for six weeks of intake. Patients received either harmaline powder capsules (10 mg) per day, standardized to reference harmaline. Each capsule contained an equivalent 10 mg harmaline powder. All capsules were manufactured and packed in the Institute of Medicinal Plants (IMP), Alborz, Iran. Control group: placebo: Placebo capsules, with the exact size, color, and appearance, were filled with fried bread (Roshd Co. Yazd, Iran). A semi-automatic capsule filler was used to fill the placebo capsules. Each container consists of 42 hard gelatin capsules for six weeks of intake. All capsules were manufactured and packed in the Institute of Medicinal Plants (IMP), Alborz, Iran. Anhedonia, depressed mood, change in appetite, sleep, and suicidal ideations. Timepoint: Week 0, 4 and 6. Method of measurement: Hamilton Depression Rating Scale score. Depression. Timepoint: Week 0, 4 and 6. Method of measurement: Beck Depression Inventory. Iranian academic center for education culture and research Approved 2020-10-06 Avicenna Research Institute Darakeh St., Shahid Beheshti University Tehran Tehran Iran (Islamic Republic of)