Effectiveness of Iranian Medicine Product: Tamarrindus Indica L. Syrup (Somalax) Compared to Placebo on Patients with Mild to Moderate Acne: A Triple_Blind Randomized Clinical Trial

Evaluation of efficacy of Somalax syrup (Iranian medicine product) in comparison with placebo in patients with mild to moderate acne

A randomized controlled clinical trial with parallel, triple blind, randomized groups

A total of 110 volunteers with acne, referred to Ahmadieh Clinic were randomly selected and randomized. Medication and placebo are offered to patients for a 12 weeks period in a similar package as the letters A and B on the door. Patient monitoring continues for 4 weeks after the medication is completed. The patient, the researcher, and the DSMB are unaware of the drug or placebo contents of the packaging.

Entry requirements: Age over 18 years Mild to moderate acne on the face Lack of a history of systemic disease when the patient has to take systemic medication No use of inducing or reducing acne medications in the last 2 weeks No facial surgery in the last month No pregnancy and no breast feeding Willingness to participate in the study Exclusion criteria: Severe acne A history of systemic disease coincides with the patient having to take systemic medication Use of inducing or reducing acne medications in the last 2 weeks Pregnancy and lactation Gastrointestinal pain and inflammation or inflammatory and ulcer disease in the gastrointestinal tract Bowel movements more than three times a day

Of the eligible candidates, 110 are enrolled Patients were randomly divided into intervention and control groups Intervention group receive oral somalax syrup 10 ml every 8 hours The control group received placebo at the same dose

Acne severity index، Quality of life score

Block Randomization

This study presents drugs and placebo in similar packaging. The only difference is the mark A and B on the packaging The manufacturer knows which symptom is related to the drug and which placebo Participants do not know whether they are taking medication or placebo The researcher does not know if she is taking medication or placebo DSMB is not aware of the type of intervention

All potential participant data is shared after unidentifiable individuals

6 months after printing the results

The data will be available to researchers working in academia and in the industry and can apply for it.

For scientific studies

Razieh Kasraie Email: dr.kasraei@yahoo.com Phone Number: 09178932624

After reviewing the applicant's request and making sure the data is used for scientific studies, the identifiable data of the study participants will be made available to the applicant.