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IRCT20180114038354N1 IRCT 2019-07-21 Gorgan University of Medical Sciences The effect of Golghand in the improvement of constipation in adults Comparative study on the effectiveness of Golghand (Persian traditional medicine product) with magnesium hydroxide in the improvement of adalt constipation 2019-07-06 anticipated 56 Complete https://irct.ir/trial/38871 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The initial selection of the samples will be available as a sampling from among the people referring to the Sayyid Gorgan educational center and observing the entry criteria. The allocation of 56 people to two groups of 28 was random. 3 constipation in adult. Intervention 1: Intervention group: They will use Golghand, Golghand is an Iranian traditional medicinal that consists of rose petals and honey, which is provide by Niaku Gorgan Pharmaceutical Company. The chemical composition of the analysis is as follows (100 grams of Golghand): 39.5 g (39%) regenerated Sugars - 19.5 g Sucrose (19%) - 10.2 g (10%) Fructose - 17.5 g total volatile oil 17%) - Geraniol 7 mg (007%) - Citroneulol 5 mg (005%) . The dosage is 20 grams daily for pationts.they use 10 grams before lunch and 10 grams before dinner with a glass of water. Patients will take medication for two weeks. Intervention 2: Control group: Participants in the control group will receive magnesium hydroxide syrup. This is provided from the Souha Pharmaceutical Company. this group receives magnesium syrup 40 cc (According to the standard dosage of 30-60 cc in Iran's generic drugs book) In two divided doses, morning (20 cc)and night Before sleeping (20 cc). Yes - There is a plan to make this available What will be shared: Information on the main outcomes and non-core outcomes will be published and analyzed and analyzed When: Start the access period after publishing the results To whom: all people Conditions: There is no limit for using the results Naming resources Where to obtain: Sayeh Ghorbanoghli dr.ghorbanoghli@goums.ac.Ir How to obtain: It will be answered as soon as possible Comments:
public Sayeh Ghorbanoghli
Gorgan university of medical science ,Hirkan blve
Gorgan Iran (Islamic Republic of) 4917953776 +98 17 3255 6862 dr.ghorbanoghli@goums.ac.ir Gorgan University of Medical Sciences scientific Sayeh Ghorbanoghli
Gorgan University of Medical Sciences, Hirkan blve
Gorgan Iran (Islamic Republic of) 4917953776 +98 17 3255 6862 dr.ghorbanoghli@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria : 1-age over 20 years 2. Have at least 2 of the following criteria; - Straining during at least 25 percent of defecations - Lumpy or hard stools in at least 25 percent of defecations -Sensation of incomplete evacuation for at least 25 percent of defecations -Sensation of anorectal obstruction/blockage for at least 25 percent of defecations -Manual maneuvers to facilitate at least 25 percent of defecations -Fewer than three defecations per week 3. during the last month,Without the use of laxatives, rarely have soft stool 4. Patient satisfaction to participate in the study 20 years no limit Both Exclousion criterias: 1- Use medications Anti-seizures, Carbamazepine, Phenobarbital, Phenytoin, Anti-neoplastic, Calcium channel blockers: Verapamil, Diuretics: Forzamide, Anti-epileptic drugs, Anti-epileptic drugs, Anti-epileptic drugs. , 5-HT antagonists, NSAIDs: ibuprofen, opioid. 2. History of mechanical and False intestinal obstruction based on previous colonoscopy or radiography or history 3 - Metabolic and endocrine diseases such as Diabetes, Hyperthyroidism and Hypothyroidism, Hypercalcemia, Hypokalemia, Pan-Hypopyothelium, Pheochromocytoma, Porphyria 4. Neurological disease and myopathic amyloidosis, autonomic neuropathy, Chagas disease, dermatomyositis, multiple sclerosis, Parkinson's disease, systemic progressive sclerosis, spinal cord injury based on biography and history 5-Special surgical and special medical conditions such as inability to move, history of Intestine surgery, ... 6. Endoscopy and radiology report in the last 5 years on abnormalities, malignancy, IBD and hemorrhoids 7-Patients with abnormal Hgb, TFT, Ca, and ESR. 8-Patients with HTN or Diabetes 9 -Patients with Asthma and Bronchitis 10.-Patients with Renal failure 11. Pregnant and nursing women K59.0 Constipation Treatment - Drugs Treatment - Drugs Intervention group: They will use Golghand, Golghand is an Iranian traditional medicinal that consists of rose petals and honey, which is provide by Niaku Gorgan Pharmaceutical Company. The chemical composition of the analysis is as follows (100 grams of Golghand): 39.5 g (39%) regenerated Sugars - 19.5 g Sucrose (19%) - 10.2 g (10%) Fructose - 17.5 g total volatile oil 17%) - Geraniol 7 mg (007%) - Citroneulol 5 mg (005%) . The dosage is 20 grams daily for pationts.they use 10 grams before lunch and 10 grams before dinner with a glass of water. Patients will take medication for two weeks. Control group: Participants in the control group will receive magnesium hydroxide syrup. This is provided from the Souha Pharmaceutical Company. this group receives magnesium syrup 40 cc (According to the standard dosage of 30-60 cc in Iran's generic drugs book) In two divided doses, morning (20 cc)and night Before sleeping (20 cc). Frequency of defecation in the week. Timepoint: Frequency of defecation in the subjects before the internvention and in the 14th day and 28th day after startinig intervention. Method of measurement: questionnaire. The amount of straining in the defecation. Timepoint: Before the beginning of the Intervention and in the 14th day and 28th day after starting the Intervention. Method of measurement: questionnaire. Frequency of lumpy or hard stools. Timepoint: Before the beginning of the Intervention and in the 14th day and 28th day after starting the Intervention. Method of measurement: questionnaire. Sensation of incomplete evacuation after defecation. Timepoint: Before the beginning of the Intervention and in the 14th day and 28th day after starting the Intervention. Method of measurement: questionnaire. Frequency of Manual maneuvers to facilitate. Timepoint: Before the beginning of the Intervention and in the 14th day and 28th day after starting the Intervention. Method of measurement: questionnaire. Occurrence of stool. Timepoint: Before the beginning of the Intervention and in the 14th day and 28th day after starting the Intervention. Method of measurement: questionnaire. Other related symptoms. Timepoint: Before the beginning of the Intervention and in the 14th day and 28th day after starting the Intervention. Method of measurement: questionnaire. Side effect. Timepoint: Before the beginning of the Intervention and in the 14th day and 28th day after starting the Intervention. Method of measurement: questionnaire. Gorgan University of Medical Sciences Approved 2019-03-03 Ethics commeitee of Gorgan university of medical scinces No 114,Dokhniyat 3 , Dokhaniyat blvd, Gorgan town Gorgan Golestan Iran (Islamic Republic of)