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IRCT20090804002288N16 IRCT 2020-02-15 Vice Chancellor for Research, Research Institute for Islamic and Complementary Medicine Effects of Sophora alopecuroides var. alopecuroides on the heroin withdrawal symptoms Comparison of the effect of Sophora alopecuroides var. alopecuroides and placebo on the clinical opiate withdrawal scale in heroin addicts: a clinical trial 2020-02-20 anticipated 100 Complete https://irct.ir/trial/45638 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization using computer generated random numbers and sequentially numbered containers each representing a block of ten patients is used for treatment assignment, Blinding description: Letters A or B are labeled on herbal drug or placebo containers. Other specifications on the labels are completely identical. Physician, nurse, patient, data collector and those who evaluate the outcome are unaware of the nature and meaning of the letters A or B on the labels. Only the main investigator knows the nature of the labels. Patients are aware that they are either in the drug or in the placebo group, but they are not aware of the type of group they are in. 3 Heroin addiction. Intervention 1: Intervention group: fifty patients use three 400 mg capsules of the Sophora alopecuroides var. alopecuroides seed hydro-alcoholic extract once orally every 24 hours for 8 days. The extract is produced in the Institute of Medicinal Plants affiliated to the Iranian Academic Center for Education, Culture and Research. The patients do not receive any other drug or treatment. Intervention 2: Control group: fifty patients use three 400 mg placebo capsules containing maltodextrin once orally every 24 hours for 8 days. The placebo is produced in the Institute of Medicinal Plants affiliated to the Iranian Academic Center for Education, Culture and Research. The patients do not receive any other drug or treatment. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD are to be shared. When: Access period starting 6 months after publication for 1 year. To whom: Researchers working in university and scientific and industrial institutes. Conditions: Only statistical analyses mentioned in the article resulting from the study for personal knowledge are permitted. Written request for access to data and documents and its aim must be certified by the highest ranking official of the work place of the requester. Where to obtain: Dr. Saeed Kianbakht with the address ACECR Institute of Medicinal plants, P.O. Box: 31375-369, Iran. How to obtain: Written request should be sent to the address Dr. Saeed Kianbakht, ACECR Institute of Medicinal Plants, P.O. Box: 31375-369, Iran. The documents or data file will be sent to the requester by email. Comments:
public Dr. Saeed Kianbakht
Institute of Medicinal Plants, ACECR Complex, Supa Boulevard, Poleh Kordan
Karaj Iran (Islamic Republic of) 3365166571 +98 26 3476 4010 kianbakht@imp.ac.ir Iranian academic center for education culture and research scientific Dr. Saeed Kianbakht
Institute of Medicinal Plants, ACECR Complex, Supa Boulevard, Poleh Kordan
Karaj Iran (Islamic Republic of) 3365166571 +98 26 3476 4010 kianbakht@imp.ac.ir Iranian academic center for education culture and research Iran (Islamic Republic of) Iranian male outpatients who according to the DSM-V criteria are dependent on heroin for at least 1 year Patients whose urinalysis result for detection of 6-acetylmorphine is positive Patients aged 18 to 70 years Patients whose heroin dose has been constant for at least one month before study Patients residing in addiction treatment camp Patients who have not used heroin for at least 5 hours before arrival in camp 18 years 70 years Male Individuals who besides heroin abuse other substances except for tobacco Patients who have other psychiatric diseases Individuals who have other important diseases like cardiac, renal and hepatic disease Individuals who have organic brain disease Individuals who have mental retardation F11.23 Opioid dependence with withdrawal Treatment - Drugs Placebo Intervention group: fifty patients use three 400 mg capsules of the Sophora alopecuroides var. alopecuroides seed hydro-alcoholic extract once orally every 24 hours for 8 days. The extract is produced in the Institute of Medicinal Plants affiliated to the Iranian Academic Center for Education, Culture and Research. The patients do not receive any other drug or treatment. Control group: fifty patients use three 400 mg placebo capsules containing maltodextrin once orally every 24 hours for 8 days. The placebo is produced in the Institute of Medicinal Plants affiliated to the Iranian Academic Center for Education, Culture and Research. The patients do not receive any other drug or treatment. Score of clinical opiate withdrawal scale. Timepoint: Before intervention and 3 and 8 days after intervention. Method of measurement: Clinical Opiate Withdrawal Scale. Patient global impression regarding efficacy of treatment. Timepoint: Eight days after intervention. Method of measurement: Visual analog scale (ten centimeter ruler). Blood level of aspartate aminotransferase. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer. Blood level of alanine aminotransferase. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer. Blood level of alkaline phosphatase. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer. Blood level of total bilirubin. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer. Blood level of direct bilirubin. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer. Blood level of indirect bilirubin. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer. Prothrombin time. Timepoint: Before intervention and 8 days after intervention. Method of measurement: chronometer. Blood level of creatinine. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer. Level of blood urea nitrogen. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer. Vice Chancellor for Research, Research Institute for Islamic and Complementary Medicine Approved 2020-02-08 Ethics committee of Iran University of Medical Sciences Hemmat Highway between Chamran and Sheykh Fazlallah Iran University of Medical Sciences Central Headquarters Fifth Floor Tehran Tehran Iran (Islamic Republic of)