Evaluatinf the safety and efficacy of a polyherbal formulation in patients with calcium renal stones
Design
Controlled clinical trial, with parallel groups, triple-blind, randomized, phase 3 on 50 patients
Settings and conduct
Eligible participants who refer to the Urology Clinic of Imam Ali Hospital or a designated private clinic in May - October 2025 will be enrolled in the study. The diagnosis of kidney stones is confirmed using KUB ultrasound or spiral computed tomography scan without contrast. Composition analysis is used to determine the type of stone. Patients are randomly assigned to two groups (placebo and drug). Block randomization (block number 4) is used to randomize patients. Both groups are allowed to use analgesics (ketorolac) and muscle relaxants (hyoscine) on a PRN basis if necessary. In addition to analgesics, the drug group will receive 10 grams of the concoction daily (divided into two doses of 5 grams, 15 minutes after lunch and dinner) for 6 days. All patients will be clinically examined at baseline and after 10 days. Ultrasound, urinalysis, and hematological and biochemical parameters will be checked at baseline and 10 days after the start of treatment.
Participants/Inclusion and exclusion criteria
included criteria: aged 18 to 60 years with kidney stones 5 mm or larger in the lower pole of the kidney
Exclusion criteria include severe urinary tract infection, acute kidney injury, CKD, diabetes, concomitant use of herbal remedies for dissolving kidney stones such as Sankol®, and pregnant or lactating women, patients with coagulation problems or taking anticoagulant medications, and individuals with a history of erosions in the gastrointestinal tract.
Intervention groups
1. Drug group: A combination of medicinal plant powders including black cumin, black cumin, ginger, and pepper mixed in a specific ratio in honey
2. Placebo group
Main outcome variables
stone size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180923041093N8
Registration date:2026-05-08, 1405/02/18
Registration timing:prospective
Last update:2026-05-08, 1405/02/18
Update count:0
Registration date
2026-05-08, 1405/02/18
Registrant information
Name
Fatemeh sadat Hasheminasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5333 8547
Email address
hashemifa67@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
Expected recruitment end date
2026-11-21, 1405/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of a polyherbal formulation in patients with calcium renal stones: A randomized, clinical trial
Public title
Herbal medicine in renal stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Kidney stones 5 mm or larger in the lower pole of the kidney
Age between 18 and 60 years old
Exclusion criteria:
severe urinary tract infection
acute renal injury
CKD
diabetes
concomitant use of herbal remedies to dissolve kidney stones such as Sankol®, Rowatinex®, Cystone®, Lithorex-B® or Urtica ZardBand®
pregnant or lactating women
patients with coagulation problems or taking anticoagulant medications
a history of ulcers or erosions in the gastrointestinal tract
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
A block randomization method (block number 4) will be used to randomize patients.
Blinding (investigator's opinion)
Triple blinded
Blinding description
To conceal allocation, sealed, numbered, opaque, and sealed envelopes will be used. Each envelope will be labeled with a serial number and delivered to a third party (clinic secretary) who will open the sealed envelope after the patient consents to participate and is assigned to a treatment group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق در پژوهش دانشگاه علوم پزشکی زاهدان
Street address
Zahedan University of Medical Sciences Campus, Dr. Hesabi Square, Zahedan, Iran
City
زاهدان
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2026-04-08, 1405/01/19
Ethics committee reference number
IR.ZAUMS.REC.1405.011
Health conditions studied
1
Description of health condition studied
Nephrolithiasis
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
renal stone size
Timepoint
At the baseline (before the intervention) and 10 days after starting the drug
Method of measurement
Ultrasound
Secondary outcomes
1
Description
BUN
Timepoint
At baseline (before the intervention) and 10 days after starting the drug
Method of measurement
blood test
2
Description
Serum creatinine
Timepoint
At baseline (before the intervention) and 10 days after starting the drug
Method of measurement
blood test
3
Description
Serum calcium
Timepoint
At baseline (before the intervention) and 10 days after starting the drug
Method of measurement
blood test
4
Description
Liver enzymes
Timepoint
At baseline (before the intervention) and 10 days after starting the drug
Method of measurement
blood test
5
Description
Urine specific gravity
Timepoint
At baseline (before the intervention) and 10 days after starting the drug
Method of measurement
Urine analysis
6
Description
24 h urine volume
Timepoint
At baseline (before the intervention) and 10 days after starting the drug
Method of measurement
Graduated container
7
Description
24 h urine calcium
Timepoint
At baseline (before the intervention) and 10 days after starting the drug
Method of measurement
Urine analysis
8
Description
24 h urine magnesium
Timepoint
At baseline (before the intervention) and 10 days after starting the drug
Method of measurement
Urine analysis
9
Description
Number of analgesics used
Timepoint
On days 1, 2, 3, 4, and 5 after the start of the intervention
Method of measurement
Asking the patient
Intervention groups
1
Description
Intervention group: IA specific amount of black pepper, black seed, black cumin, and ginger rhizome powder is ground and mixed with honey. The patient consumes 5 grams of this mixture daily after lunch and 5 grams after dinner for 6 days.
Category
Treatment - Drugs
2
Description
Control group: Placebo (one thirtieth of the herbal powder used as intervention drug mixed in honey). The patient takes 5 grams of this mixture daily after lunch and 5 grams after dinner for 6 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Behzad Naroui
Street address
Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5570
Email
bahzadnarouei@gmail.com
2
Recruitment center
Name of recruitment center
Dr. Behzad Naroui Clinic
Full name of responsible person
Behzad Naroui
Street address
Khayyam Street, between Khayyam Square and Modarres
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5570
Email
bahzadnarouei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Ansari Moghadam
Street address
Dr. Hesabi Square - Persian Gulf Boulevard -
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3341 9432
Email
Ar.ansarimoghadam@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Habib Ghaznavi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Dr. Hesabi Square - Persian Gulf Boulevard -
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
dr.ghaznavi@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hasheminasab
Position
Assistant professor ل
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Dr. Hesabi Square - Persian Gulf Boulevard
City
Zahedav
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
00985533372151
Email
hashemifa67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hasheminasab
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Dr. Hesabi Square - Persian Gulf Boulevard
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
00985533372151
Email
hashemifa67@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
After the study, information about the main outcome will be shared
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
For academic and scientific researchers only
Under which criteria data/document could be used
Only in line with the analysis and research related to the main title of this study
From where data/document is obtainable
Email to hashemifa67@gmail.com
What processes are involved for a request to access data/document
The data will be provided to the applicant within one month after reviewing and confirming the request.