Relieving the pain and inflammation caused by Calcaneal spurs; comparing the effect of the mentioned compounds with plasma therapy and the ointment of Commiphora Mukul plant; lysis of the bone appendage of the heel; Muscle relaxation
Design
Clinical trial with a control group, with parallel groups, double-blinding, non-randomized, phase 3 on 88 patients.
Settings and conduct
This study will be done in Dr. Derakhshan's clinic. The study population is patients with Calcaneal spur. Blinding: double-blind. Method of blinding: patients will be divided into 11 groups that medicinal compounds used with different concentrations will be considered equivalent to English letters that only the researcher and clinical caregiver know which group each drug is assigned to and the test results will be provided to the data analyst in the same way.
Participants/Inclusion and exclusion criteria
Inclusion criteria: male and female patients with heel spurs; Age 18 to 80 years; Weight 60 to 150 kg Exclusion criteria: pregnant and Nursing mothers; Taking any medication or undergoing distorting surgery
Intervention groups
Intervention groups: In this study, there are 10 intervention groups, which will be named with English alphabets. In the first to third groups, fat-based cream with hop plant extract with different concentrations will be used. In the fourth, fifth and sixth groups, peppermint plant extract with different concentrations will be used as an cream. In the 7th, 8th and 9th groups, the combination of hop and peppermint plant extracts are used with different concentrations. The tenth group also uses common treatments, and the results will be compared with each other. Control group: In this group, moisturizing cream will be used as a placebo.
Main outcome variables
Reducing Pain and Inflammation; Muscle relaxant; Additional bone tissue lysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240916063066N2
Registration date:2024-10-19, 1403/07/28
Registration timing:prospective
Last update:2024-10-19, 1403/07/28
Update count:0
Registration date
2024-10-19, 1403/07/28
Registrant information
Name
Mohsen Derakhshan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3339 8564
Email address
derakhshan.m@skums.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2025-06-10, 1404/03/20
Expected recruitment end date
2025-07-10, 1404/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of hydroalcoholic extract of Humulus lupulus and Mentha piperita with surgery and common treatments to improve Calcaneal spur
Public title
Investigating the effect of the combination of hydroalcoholic extract of Common hop and peppermint on the improvement of Calcaneal spur
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients suffering from mild, moderate and severe heel spurs with or without bone damage
Age 18 to 80 Years Old
Body Weight 60 to 150 kg
Gender Male & Female
Daily Activity Rate from 0 to 24 Hours
Exclusion criteria:
Pregnant and Nursing mothers
Taking Confounding Medications such as Corticosteroids and NSAIDs
Confounding Occupations Based on the Place, Manner and Hours of Activity That are Effective on The Improvement or Non-Improvement of the Disease.
Confounding Surgical Records Based on Orthopedic, Brain, or any Type of Surgery That Disrupts the Motor System.
Suffering from diseases of the motor system Suffering from other movement disorders except calcaneal spur
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is a Double Blind Method. in which the Participant and the Data Analyst do not know about the Drug used;
First, Information about the Drugs Used will be Available to all Patients; Then the patients are divided into 11 groups of 8 people; that the medicinal Compounds Used with Different Concentrations are Considered Equivalent to the English letters, A to I, Heel pad and Commiphora Mukul herbal cream J and Placebo K; so that only the Researcher and Clinical Caregiver know which Group each Drug is Assigned to; And the Test Results will be Provided to the Data Analyst in the same way.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of Islamic Azad University - Shahrekord Branch
Street address
Rahmatiyeh Qtr, Islamic azad university Shahrekord branch
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Approval date
2024-09-08, 1403/06/18
Ethics committee reference number
IR.IAU.SHK.REC.1403.243
Health conditions studied
1
Description of health condition studied
Calcaneal spur
ICD-10 code
M77.3
ICD-10 code description
Calcaneal spur
Primary outcomes
1
Description
pain relief
Timepoint
At the Beginning of the Study (before the start of the Intervention) and once a Week until the end of the Intervention and Completion of the Treatment
Method of measurement
Clinical examinations; ًQuestionnaires
2
Description
Inflammation reduction
Timepoint
At the Beginning of the Study (before the start of the Intervention) and once a Month until the end of the Intervention and Completion of the Treatment
Method of measurement
Clinical examinations; Radiograph of the heel; Erythrocyte Sedimentayion Rate (ESR)by Blood Sampling; C-reactive protein measurement by blood sampling (CRP)
3
Description
Muscle relaxation
Timepoint
At the Beginning of the Study (before the start of the Intervention) and once a Week until the end of the Intervention and Completion of the Treatment
Method of measurement
Clinical examinations; Questionnaires
4
Description
Additional bone tissue lysis
Timepoint
At the Beginning of the Study (before the start of the Intervention) and once a Month until the end of the Intervention and Completion of the Treatment
Method of measurement
Radiograph of the heel
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The first group is group A, in this group, the extract of Humulus lupulus plant, which is obtained from its root and stem, and the hydroalcoholic extract were prepared in the laboratory of Azad University, Shahrekord branch, and fat- based Cream on with concentration1% will be used on 8 patients locally, twice a day for 120 days on affected heel.
Category
Treatment - Drugs
2
Description
Intervention group 2: The second intervention group, group B, which will be tested topically on 8 patients from the Humulus lupulus plant extract according to the mentioned cases of group A with the concentration 2% in the form of a fat-based Cream twice a day for 120 days will be use.
Category
Treatment - Drugs
3
Description
Intervention group 3: The third intervention group, which is called group C, will be used the Humulus lupulus plant based on the explanations mentioned in group A in the form of a fat-based Cream with a concentration 4%, twice a day and for 120 days on the affected Heel of 8 patients that will be used topically.
Category
Treatment - Drugs
4
Description
Intervention group 4: In the fourth group, which is called group D, fat-based Cream containing hydroalcoholic extract of Mentha piperita plant with the concentration of 6% will be used which will be tested locally on affected Heel twice a day for 120 days on 8 patients.
Category
Treatment - Drugs
5
Description
Intervention group 5: In group E, which is the fifth group of comparison, the same compound as group four but with different concentration 10% locally twice a day for 120 days It will be used on 8 patients.
Category
Treatment - Drugs
6
Description
Intervention group 6: In the sixth intervention group, group F, is also similar to the previous group, with the same compound as group four, but with different concentration 14% and locally twice a day for 120 days will be tested on 8 patients.
Category
Treatment - Drugs
7
Description
Intervention group 7: In the seventh intervention group or groupG, the combination of the extracts of Humulus lupulus and Mentha piperita plants will be used in the form of a fat-based Cream with the same concentration mentioned in Group 1th and 6th will be tested locally on the joints of 8 patients twice a day for 120 day.
Category
Treatment - Drugs
8
Description
Intervention group 8: In group H, the combination of hydroalcoholic extract of Humulus lupulus plants and Mentha piperita with the same concentration as group 2th and 5th is used as a fat-based Cream. This Cream will be tested twice a day for 120 days on all affected joints of 8 patients.
Category
Treatment - Drugs
9
Description
Intervention group 9: In group I, which is the ninth intervention group, there is also a combination of hydroalcoholic extracts of Humulus lupulus and Mentha piperita plant with the same concentration as groups 3th and 4th in the form of a fat-based Cream is used. This Cream will be tested twice a day for 120 days on all affected joints of 8 patients.
Category
Treatment - Drugs
10
Description
Intervention group 10: Intervention group include In the last intervention group, group J of combined treatments: the use of 5 cc platelet-rich plasma (PRP), heel pad and Keroya cream containing the extract of Commiphora Mukul plant, which the patient uses topically.
Category
Treatment - Drugs
11
Description
Control group: In the control group Simple moisturizing cream it will be prescribed as a placebo, which will be used to control and evaluate the psychological impact and indoctrination of the 8 patients in this group on the treatment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Derakhshan Clinic, Kausar Doctors Building
Full name of responsible person
Mohsen Derakhshan
Street address
Dr. Derakhshan Clinic, Abi SQ, South Mharram St. 12, Kausar Doctors Buildingo
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816885535
Phone
+98 38 3227 2445
Email
Afshin23450@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshid Kheiri
Street address
Rahmatiyeh Qtr, Islamic azad university Shahrekord branch
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1060
Email
kheiri.f@iaushk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?