The evaluation of four plants extract effectiveness on renal stone passage in patients whom underwent extracorporeal shockwave lithotripsy, A double blind randomized clinical trial

To investigate the effect of consuming four plant extracts on kidney stone excretion following extracorporeal lithotripsy

A concealed, randomized, blinded, sham controlled clinical trial, phase 3 design of 62 patients

We select 62 patients referred to the lithotripsy department of Imam Jafar Sadeq Hospital in Meybod with the aforementioned conditions whom undergo an abdominopelvic CT scan without contrast before lithotripsy. Then, the patient undergo lithotripsy, and randomized into two groups by concealed envelope. One group is given antibiotics and analgesics and syrup of four herbal extracts, the other receive placebo for 40 days (10 cc, three times a day). Then, a kidney ultrasound has been done. At the end of the study, the presence or absence of stones and the size of the stone remnants are checked and compared between two groups.

Inclusion criteria: 1. The stone size is between 1-2 cm. 2. The stone's Hounsfield number is below 1000. 3. The age is over 18 years. 4. The distance between the stone and the skin surface is less than 10 cm. Exclusion criteria: 1. Urinary tract infection symptoms 2. History of DJ insertion; 3. Does not consent to participate in the study 4. Developing post-ESWL complications 5. Does not complete post-lithotomy follow-up. 6. Any anatomical abnormalities in the kidney undergoing lithotripsy. 8. Pregnant women and children. 9. Allergy to any of the ingredients of the prescribed drug

The intervention group (31 eligible patients) is given antibiotics, painkillers, and extracts of four herbs for 40 days (three times a day, 10 cc each time). The control group (31 eligible patients) is given antibiotics, painkillers, and a placebo for 40 days (three times a day, 10 cc each time).

Stone passage rate after extracorporeal lithotripsy following drug use

They are randomly divided into two groups using the envelope method, which is provided to the patients by the secretary of the stone crusher department of Meybod Hospital. In order to randomly allocate eligible patients into two groups, we consider patients numbered 1 to 62 in the order of their referral, and then, using the Random Allocation Version 2 software, a random sequence is generated and individuals are placed in two intervention or control groups (A, B). The method of generating random codes is simple random. In order to blind the random allocation, the random allocation list is provided to another person who is outside the study, and the type of intervention is asked from this person based on the list by text message or phone.

Those who have been kept blind include: 1) the participants who are the same patients with kidney stones who are candidates for extra-organ stone crushing in the Stone Crushing Center of Imam Jafar Sadegh Meybod Hospital were included in the study under the conditions of entry and with consent. 2) The evaluator is an experienced and single radiologist who subjects all participants to kidney ultrasound after 40 days.

A part of the data such as the information related to the main outcome or the like can be shared.

Access to study documentation after results are published

It will be available for researchers working in academic and scientific institutions, and also people who are working in the industry can apply for them.

For secondary studies

Traditional Medicine Research Center, Yazd Shahid Sadoughi University of Medical Sciences

The request sent will be reviewed by the members of the center. If the members agree, they will be notified.

There is no further information.