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IRCT20180219038798N1 IRCT 2018-08-06 Shiraz University Clinical efficacy of the essence oil of Zartaria multiflora on human liver hydatid cyst Clinical efficacy of the essence oil of Zartaria multiflora on human liver hydatid cyst in comparison with Albendazole 2015-02-20 anticipated 30 Complete https://irct.ir/trial/29767 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 1-2 Hydatid disease (Hydatid cyst). Intervention 1: Intervention group: 15 patients consumed orally the 20 mg soft capsules of Zataria multiflora essential oil (produced by Barij Essence Pharmaceutical Company, Iran) 3 times a day for 6 months (180 consecutive days). Before the start of treatment and 2, 4 and 6 months after the start of treatment, the size of the cysts were measured by sonography. Simultaneously, biochemical and hematological analysis was performed on the blood samples of patients to assess the possible side effects. At the end of study, the mean size of the cysts and the results of the liver and kidney function tests were compared statistically between the patients of two treatment groups. Intervention 2: Control group: The patients of this group (15 patients) consumed orally the 400 mg tablets of albendazole (produced by CIPLA LTD, India) 2 times a day for 6 months. All measurements and tests were performed exactly as in the intervention group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Unawareness from the consent of the participants
public Dr. Mohammad Moazeni
Bajgah area< School of Veterinary Medicine
Shiraz Iran (Islamic Republic of) 71441-69155 +98 71 3228 6950 moazeni@shrazu.ac.ir Shiraz University scientific Dr. Mohammad Moazeni
Bajgah area, School of veterinary Medicine
Shiraz Iran (Islamic Republic of) 71441-69155 +98 71 3228 6950 moazeni@shirazu.ac.ir Shiraz University Iran (Islamic Republic of) Patients who accepted the treatment protocol by signing the appropriate informed consent, Patients with hepatic hydatid cysts smaller than 5 cm, Patients with uncomplicated hydatid cysts (non calcified and non infected to bacterial infections), Patients who were not simultaneously infected to pulmonary hydatid disease 20 years 60 years Both Refusal of treatment at each stage of the treatment period Patients with symptoms of complicated cysts (infection, abscessation). Enlargement of the cysts during the course of treatment. Adverse drug reactions leading to discontinuation of the treatment Patients who don’t refer for periodic examinations and necessary tests Recurrence of the disease Treatment - Drugs Treatment - Drugs Intervention group: 15 patients consumed orally the 20 mg soft capsules of Zataria multiflora essential oil (produced by Barij Essence Pharmaceutical Company, Iran) 3 times a day for 6 months (180 consecutive days). Before the start of treatment and 2, 4 and 6 months after the start of treatment, the size of the cysts were measured by sonography. Simultaneously, biochemical and hematological analysis was performed on the blood samples of patients to assess the possible side effects. At the end of study, the mean size of the cysts and the results of the liver and kidney function tests were compared statistically between the patients of two treatment groups. Control group: The patients of this group (15 patients) consumed orally the 400 mg tablets of albendazole (produced by CIPLA LTD, India) 2 times a day for 6 months. All measurements and tests were performed exactly as in the intervention group. Reduction in the size of hydatid cysts. Timepoint: Before the start of treatment and after all treatment periods (totally 4 times). Method of measurement: By sonography. Shiraz University Approved 2018-02-03 Ethics committee of Shiraz University of Medical Sciences Zand street Shiraz Fars Iran (Islamic Republic of)