Investigating the therapeutic effect of herbal supplement (Herbal topical cream containing lavender, mint, cinnamon, ginger, moringa, poppy extract and clove extract.) in order to reduce chemotherapy-induced neuropathy, muscle pain and response to treatment
Investigating the therapeutic effect of herbal supplement (Herbal topical cream containing lavender, mint, cinnamon, ginger, moringa, poppy extract and clove extract.) in order to reduce chemotherapy-induced neuropathy, muscle pain and response to treatment
Design
A double-blind clinical trial with a control group, with parallel groups, randomized, phase 3 was conducted on 80 patients.
Settings and conduct
This study is to reduce pain caused by neuropathy and muscle pain, which will be conducted in Omid and Ghaem Hospital affiliated to Mashhad University of Medical Sciences. People receive a topical cream containing lavender, moringa, poppy extract, which is based on vaseline and ostrich oil. This study has been double-blind, which will be blind for the people participating in the study as well as the collectors.
Participants/Inclusion and exclusion criteria
Inclusion criteria. Male or female 19 to 60 years old with neuropathic pain or chronic muscle pain.
Exclusion criteria: pregnant or lactating women, patients with autoimmune disorders
Intervention groups
The intervention group includes patients with neuropathic pain or chronic joint pain who receive herbal cream.
The comparison group includes patients with neuropathic pain or chronic joint pain who receive placebo cream.
Main outcome variables
Educing the amount of pain caused by neuropathy and joint pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230712058750N1
Registration date:2023-12-29, 1402/10/08
Registration timing:registered_while_recruiting
Last update:2023-12-29, 1402/10/08
Update count:0
Registration date
2023-12-29, 1402/10/08
Registrant information
Name
AMIR AVAN
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 6015
Email address
amir_avan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the therapeutic effect of herbal supplement (Herbal topical cream containing lavender, mint, cinnamon, ginger, moringa, poppy extract and clove extract.) in order to reduce chemotherapy-induced neuropathy, muscle pain and response to treatment
Public title
The effect of herbal topical cream in reducing pain caused by neuropathy and joint pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients have symptoms of chronic muscle and joint pain.
Patients with neuropathic pain caused by chemotherapy
Exclusion criteria:
Pregnant or lactating woman
Patients who have abdominal abscess at the time of visit.
Patients with bacterial infection.
Patients who use opioids on a daily basis.
Possible side effects of treatment
Age
From 19 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This randomized study will be of the block type, the type of double-blind blinding, and the method of concealing the allocation of the study will be sealed opaque envelopes, which is the SNOSE method (sequentially numbered, opaque, sealed envelopes) by one of the team members and Random numbers will be prepared and printed and will be placed inside the envelope. The door of the envelope will be closed and its contents cannot be seen from the outside. Then, first, the purpose of the study will be explained to the person who meets the specified conditions, and if the person wishes, the form will be filled. Sign the informed consent and take an envelope and then open it and enter the person in the intervention or control group based on the contents of the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind experiment that will be blind for the people participating in the study. Herbal pain reliever cream and placebo cream were prepared based on Vaseline and ostrich oil (it is the same in terms of color and shape, in order to make the aroma and smell of the placebo cream similar to the herbal cream, inside the containers before filling with the placebo cream, with a solution containing The plants and extracts used were washed).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Medical School of Mashhad University of Medical Sciences
Street address
vakil abad sq., faculty of medicine
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2023-06-27, 1402/04/06
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.185
Health conditions studied
1
Description of health condition studied
People with neuropathy or joint and muscle pain
ICD-10 code
G62.0
ICD-10 code description
Drug-induced polyneuropathy
Primary outcomes
1
Description
Pain and tingling
Timepoint
before intervention and 10 min, 1 hours , 6 hours after intervention
Method of measurement
Neuropathic Pain Scale (NPS) and Guidelines for the Pharmacological Treatment of Peripheral Neuropathic Pain: Expert Panel Recommendations for the Middle East Region
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients with neuropathic pain and joint pain, 50 grams of topical herbal cream, one gram of lavender, three grams of clove extract, one and a half grams of mint, two grams of cinnamon, half a gram of ginger, two tenths of grams of moringa, one cc of poppy extract of this cream. Cream based on vaseline and ostrich oil (made in Mashhad Medical Sciences Faculty) was used topically daily for 4 weeks during pain.
Category
Treatment - Drugs
2
Description
Control group: patients with neuropathic pain and joint pain used placebo cream (made in Mashhad Medical Sciences Faculty) topically daily during pain for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid and ghaem Hospital, Mashhad University of Medical Sceinces
Full name of responsible person
Amir Avan
Street address
Medical genetics, faculty of medicine, Mashhad University of medical Sciences
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2298
Email
avana@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Avan
Street address
no 1, medical genetics, faculty of medicine, MUMS
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2298
Email
avana@mums.ac.ir
Grant name
MUMS
Grant code / Reference number
4011572
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
AMIR AVAN
Position
University professor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Genetics
Street address
Medical genetics, faculty of medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2298
Fax
Email
amir_avan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
AMIR AVAN
Position
University professor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Genetics
Street address
23univercity Ave,taheri5 Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3841 6015
Fax
Email
amir_avan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Avan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
No 1, medical genetics dept, faculty of medicine, ferdowsi University, mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
009838002298
Email
avana@mums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
We will be ready to share all the collected de-identified paticipant data (IPD) to other researchers after the end of study.
When the data will become available and for how long
starting in January 2025
To whom data/document is available
Sharing of all collected de-identified participants data (IPD) will be started immediately after publication. people working in academic institutions or people working in businesses
Under which criteria data/document could be used
The collected de-identified participants data (IPD) will be only shared to those recipients who commit themselves to use them only for patients. They also should commit themselves to share these data with other organization only after asking permission from the original source.
From where data/document is obtainable
Data/Documents will be obtainable by sending an e-mail to avana@mums.ac.ir
What processes are involved for a request to access data/document
Data/Documents will be obtainable by sending an e-mail to avana@mums.ac.ir