Evaluation of efficacy of “Ziziphus Vulgaris” formula to prevent “drug induced liver enzyme disorder” in pulmonary tuberculosis Patients

Evaluation of efficacy of "Ziziphus Vulgaris" formula to prevent “drug induced liver enzyme disorder” in pulmonary tuberculosis patients

Double blind randomized clinical trial (block randomization); Sample size: 70; Drug group: 35, placebo group: 35.

All patients that referring to health centers in Golestan province, who are diagnosed as new pulmonary tuberculosis that must be treated by DOTs protocol entering the study. If they have criteria for entering the study, they will be introduced to the researcher.After initial liver tests, interventions begin for 4 weeks. At 14 and 28, liver tests are re-measured. During the study, patients can be contact to researcher if they have any questions or problems.

Entering: Declaration of written consent; Age from 30 to 65 years; A new diagnosis of pulmonary tuberculosis ; No relapse or drug resistance; No history of HIV-positive; No history of renal failure; No history of all types of acute, chronic and alcoholic hepatitis; No history of cirrhosis; No Pregnancy and lactation. Non-entering: Patients under treatment with other herbal supplements; Lack of appropriate verbal communication; Patients with Oral intolerance; No tendency to take herbal medicine; No tendency to consume syrup.

Drug group: Jujube syrup, with a dose of 10 cc twice daily (morning fasting and night before bedtime) for 4 weeks. Placebo group: Placebo syrup, with a dose of 10 cc twice daily (morning fasting and night before bedtime) for 4 weeks. For each groups, routine anti-TB treatment will be implemented in accordance with the DOTs Country Program.

Serum level of alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase.

Patients referring to health centers diagnosed with TB by a doctor who have criteria for entry into the study are included in the study. 70 samples will be assigned to two groups using the Block Random allocation method. The sample allocation will be done using the software, and samples will be assigned in binary blocks, ie, random numbers for blocks from Through the application. Patients will be placed in two groups A and B using the Randomization Block. Group A is given to the group B and placebo. In order to hide the random allocation of the groups, the method of packet envelopes will be used. Then the envelopes are opened for the patient, and the treatment is determined.

Due to the similarity of the drug & placebo, after randomization and allocation of subjects to the two groups of study, the drugs were placed in the box and encoded. In this way, the patient and expert assessor and researcher will not be aware from type of intervention. Jujube & placebo syrups are similar in appearance and concentration, and until the end of the data analysis, they will remain hidden from the study's participants and participants (double blind).