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Evaluation of the effectiveness of herbal anti-pain ointment (containing therapeutic oils) to treat the types of pains in musculoskeletal pain patients

 View older revisions Content changed at 2024-04-06, 1403/01/18

Protocol summary

Study aim
The aim of this study is to evaluate the therapeutic effectiveness of an herbal anti-pain ointment containing medical plants (Turmeric, Ginger, Pepper, and therapeutic oils) to treat the types of musculoskeletal pains, at different ages.
Design
Randomized and blinded clinical trial, with a parallel-group, 50 patients in the phase II and 100 patients in the phase III. Rand function of Excel software is used for randomization.
Settings and conduct
Office of Bone specialty and Orthopedic specialist/Orthopaedist (the 3rd floor, No. 822, between Esharat-e St. and Farabi St., station of Chaharsad Dastgah, Piroozi St.). The patient is selected by a specialist physician at random from among patients with musculoskeletal pain. It is suggested that the Ointment be used every day (1-2 times) for 1-2 months (based on the pain severity). Participants with musculoskeletal pains, study assessors, and data analysts are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Existence of one of the types of musculoskeletal pains; Exclusion criteria: No criteria
Intervention groups
Intervention group: The patients of this group use the herbal anti-pain ointment every day (1-2 times) for 1-2 months (based on the pain severity), topically. Intervention group (Control): This group is the same patients in group 1 who used drugs, analgesia, or other products (before using anti-pain ointment). This group has been selected to compare the effectiveness of herbal anti-pain ointment with drugs and analgesia.
Main outcome variables
Evaluation of skin sensitivity, speed and the level of effectiveness, as well as the potency of herbal anti-pain ointment to relieve/stop the pain

General information

Reason for update
Given the end of clinical trial and analysis of obtained results, information has been updated to present the report as well as assess the effect of herbal anti-pain ointment on musculoskeletal pains and study results in the form of published article.
Acronym
IRCT registration information
IRCT registration number: IRCT20211231053573N1
Registration date: 2022-07-17, 1401/04/26
Registration timing: registered_while_recruiting

Last update: 2024-04-06, 1403/01/18
Update count: 1
Registration date
2022-07-17, 1401/04/26
Registrant information
Name
Saeed Heidari keshel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7790 3868
Email address
saeed.heidari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-16, 1401/04/25
Expected recruitment end date
2022-09-16, 1401/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of herbal anti-pain ointment (containing therapeutic oils) to treat the types of pains in musculoskeletal pain patients
Public title
Evaluation of the effectiveness of herbal anti-pain ointment to treat the types of musculoskeletal pains at different ages
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with the transient/acute/chronic musculoskeletal pains
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
More than 1 sample in each individual
Number of samples in each individual: 2
Given that musculoskeletal pain can occur in the back, knees, spine, shoulders, arms, etc.; hence, 2 or more samples can be described in each patient. Likewise, 2 or more samples can be described in patients with the psoriatic arthritis pain
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants with musculoskeletal pains are blinded to study group allocation and determine the therapeutic effectiveness of the ointment for reducing pain and avoiding prejudice against herbal ointment. In this case, an ointment tube (without knowing its contents) is provided to the patient. In addition, study assessors and data analysts are blinded to perform analysis without prejudice. The researcher, clinical caregiver (doctor and physiotherapist), and Data Safety and Monitoring Committee are aware of the herbal structure and nature of the ointment
Placebo
Not used
Assignment
Parallel
Other design features
The anti-pain ointment is the combination of medical plants that affect in decreasing and at stopping pain (chemical ingredient-free)

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Vice-Chancellor in Research Affairs- Shahid Beheshti University of Medical Scien
Street address
Block A, 13th floor, Ministry of Health and Medical Education, Between South Falamek St. and Zarafshan St., Sima-ye-Iran St., Shahrak-e Qods (Gharb).
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2020-11-22, 1399/09/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.758

Health conditions studied

1

Description of health condition studied
The types of musculoskeletal pains
ICD-10 code
R29-8
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue

2

Description of health condition studied
Back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

3

Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor

4

Description of health condition studied
Sciatica
ICD-10 code
M54.3
ICD-10 code description
Sciatica

5

Description of health condition studied
Neuro-Muscular pain
ICD-10 code
M41.46
ICD-10 code description
Neuromuscular scoliosis, lumbar region

6

Description of health condition studied
Arthritis
ICD-10 code
G98.0
ICD-10 code description
Neurogenic arthritis, not elsewhere classified

7

Description of health condition studied
Psoriatic arthritis pain
ICD-10 code
L40.52
ICD-10 code description
Psoriatic arthritis mutilans

Primary outcomes

1

Description
Evaluation of skin sensitivity, speed and the level of effectiveness, as well as the potency of herbal anti-pain ointment to relieve/stop the pain
Timepoint
Evaluation of skin sensitivity (days 1, 3,7, and 14- Phase II); Evaluation of speed and the level of effectiveness, as well as the potency of herbal anti-pain ointment to relieve/stop the pain (the first 10 min, after 3 h, in weeks 1-6, in phase III)
Method of measurement
Observe the skin to check for sensitivity/allergies. Questionnaire to assess the potency, speed, and the level of effectiveness of herbal anti-pain ointment to relieve/stop the pain

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the first intervention group includes patients who have used herbal anti-pain ointment. In the intervention group, each patient is evaluated before ( the first intervention group) and after (the control group) using the herbal anti-pain ointment (in terms of reducing pain). The herbal anti-pain ointment contains a combination of medical plants (Turmeric, Ginger, Pepper, and therapeutic oils of Sesame, Black seed, Citrus, Olive, and rose) to treat the types of musculoskeletal pains at different ages, and active ingredients are extracted as an oily extract in the process of herb/plant maceration in oil. This ointment is chemical ingredient-free and has been made in the R&D department of Vanda Noyan Oxin Teb Company, based in Shahr-e-Kord Health Technology Incubation center - Shahr-e-Kord University of Medical Sciences. . It is suggested that the anti-pain ointment be used every day (1-2 times) for 1-2 months (based on the pain severity). Participants with musculoskeletal pains, study assessors, and data analysts are blinded.
Category
Treatment - Drugs

2

Description
Control group: This group includes the same patients as the first intervention group who used drugs, analgesia, or other products (before using anti-pain). This grouping is to compare the effect of herbal anti-pain ointment with other products consumed by the patient.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Office of Bone specialty and Orthopedic Specialist/Orthopaedist
Full name of responsible person
Dr. Mohammad Zahraei
Street address
The 3rd Floor, No. 822, between Esharat-e st. and Farabi st., station of Chaharsad Dastgah, Piroozi st..
City
Tehran
Province
Tehran
Postal code
1716673337
Phone
+98 21 3335 3394
Email
mhdzahrayee@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vanda Noyan Oxin Teb Company
Full name of responsible person
Azadeh Izadyari Aghmiuni
Street address
First Floor, No. 391, Tabnak Building, Hesam-od-Din st., Jeyhoon st.
City
Tehran
Province
Tehran
Postal code
1353917131
Phone
+98 21 5574 5527
Email
azadeh.izadyari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vanda Noyan Oxin Teb Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Vanda Noyan Oxin Teb Company
Full name of responsible person
Azadeh Izadyari Aghmiuni
Position
CEO and Researcher/Formulator
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
First floor, No. 391, Tabnak Building, Hesam-od-DinSt., Jeyhoon St.,
City
Tehran
Province
Tehran
Postal code
1353917131
Phone
+98 21 5574 5527
Email
azadeh.izadyari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Vanda Noyan Oxin Teb Company
Full name of responsible person
Azadeh Izadyari Aghmiuni
Position
CEO and Researcher/Formulator
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
First floor, No. 391, Tabnak Building, Hesam-od-DinSt., Jeyhoon St.,
City
Tehran
Province
Tehran
Postal code
1353917131
Phone
+98 21 5574 5527
Email
azadeh.izadyari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Vanda Noyan Oxin Teb Company
Full name of responsible person
Ali Aghababai beni
Position
Chairman of the Board and Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
No. 34, Imam Khomeini St.
City
Ben
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8858195749
Phone
+98 38 3372 3233
Email
aliaghababai@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Patient report form/questionnaire
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
Researchers working in academic/scientific institutes (university) and specialist doctors
Under which criteria data/document could be used
Additional studies on musculoskeletal pain derived from other diseases such as scleroderma, etc.
From where data/document is obtainable
Email to the corresponding author of the published article
What processes are involved for a request to access data/document
The response to the requested email by the corresponding author (1 week) and if the request is approved, the documents/data will be sent in less than 3 weeks.
Comments

Trial results

Please tick if results have been published
Yes
Summary result posting date
2024-04-06, 1403/01/18
Table of baseline comparison
Group Group 1: the receiving patients of the herbal anti-pain bio-ointment [no other topical analgesics, and oral NSAIDs and/or COX-2 inhibitors] Group 2: the same patients in group 1 who used drugs, analgesia, or other products (up a 1-week before using anti-pain bio-ointment) p-value
Female 35 (70%) 35 (70%) > 0.9999
Male 15 (30%) 15 (30%) > 0.9999
The types of musculoskeletal pains
rheumatoid arthritis 1 1 > 0.9999
Osteoarthritis 10 10 > 0.9999
muscle crampsor strain 2 2 > 0.9999
shoulder and neck pains 8 8 > 0.9999
arm, tennis elbow, forearm, andwrist pains 7 7 > 0.9999
neuromuscular, sciatica and back pains 7 7 > 0.9999
bone painor chronic pain that has continued long after the fracture finished healing 6 6 > 0.9999
spinal disc problems and spinal pains 2 2 > 0.9999
pain caused by torn meniscus 1 1 > 0.9999
pains caused by trauma (damage to the tissue), physical activity or exercise 6 6 > 0.9999
Taking sedatives before intervention
Yes 47 (94%) 47 (94%) > 0.9999
No 3 (6%) 3 (6%) > 0.9999
Regular usage of prescribed bio-ointment
Always 46 (92%) 41 (82%) > 0.9999
Most of the time 4 (8%) 9 (18%) > 0.9999
Taking sedative in first month
Never 46 (92%) 3 (6%) < 0.0001
Sometimes 1(2%) 0 0.6502(p > 0.05)
One per day 3 (6%) 0 0.6017(p > 0.05)
Two or three per day 0 47 (94%) < 0.0001
Taking sedative in second month
Never 47 (94%) 3 (6%) < 0.0001
Sometimes 2 (4%) 0 0.5941(p >0.05)
One per day 1(2%) 0 0.6278(p > 0.05)
Two or three per day 0 47 (94%) < 0.0001
Age (year)
10-15 years 3 3 > 0.9999
16-30 years 15 15 > 0.9999
31-50 years 11 11 > 0.9999
50 years < 21 21 > 0.9999
BMI Lower than 29 kg/m2 Lower than 29 kg/m2 > 0.9999

Participant flow diagram
50 and 100 patients (Phase II and III)
Inclusion criteria:(1) The existence of one of the types of musculoskeletal pains (transient/ acute/ chronic)(2) Age between 10 and 88 years. Exclusion criteria:(1) The allergy to the fabricated herbal bio-ointment used during the study2) Body mass index (BMI) of 30 kg/m2 and above.
Selecting patients based on the inclusion and exclusion criteria, as double-blind, randomized controlled, parallel-group trial study, with an informed consent by the participants before the start of the study
Intervention Groups: The patients with transient/acute/chronic musculoskeletal pains (with International Classification of Diseases-10 [ICD-10], diseases of the musculoskeletal system and connective tissue including R29.8 Other and unspecified symptoms and signs involving the nervous and musculoskeletal systems, M54.5 Low back pain, M05 rheumatoid arthritis, M54.3 Sciatica, M41.4 Neuromuscular scoliosis, and M13 arthritis), patients diagnosed by orthopaedist were selected for this study 
 Group 1: The receiving patients of the herbal anti-pain bio-ointment used it every day (1-2 times) for 2 months, topically [no other topical analgesics, and oral drugs NSAIDs and/or COX-2 inhibitors].
Effectiveness assay (%)(1) Speed of pain relief(2) The time of pain relief (3) Warming the damaged area 
Group 2: The same patients in group 1 who used drugs, analgesia, or other products (up to a 1-week before using anti-pain bio-ointment); this group was selected to compare the effectiveness of herbal anti-pain bio-ointment with other drugs and analgesia.
Assessment of Satisfaction (%) and Final results (%)

Table of variable outcomes' results
Effectiveness Group 1: the receiving patients of the herbal anti-pain bio-ointment [no other topical analgesics, and oral NSAIDs and/or COX-2 inhibitors] Group 2: the same patients in group 1 who used drugs, analgesia, or other products (a 1-week before using anti-pain bio-ointment) p-value
Speed of pain relief (%)
< 10 min 40 0 0.0027(p < 0.05)
<10-20 min< 10 3 0.1274
30 min 34 12 0.0761(p < 0.1)
> 30 min 16 35 0.0643(p < 0.1)
The time of pain relief (%)
> 3 h 60 14 <0.001
<2-3 h < 36 52 0.0172(p < 0.05
< 1 h 4 34 <0.001
Effectiveness of the formulated ointment than other treatments (%)
stronger 76 - -
equal 20 - -
weaker 4 - -
Satisfaction (%) From bio-ointment
Very satisfaction 52 - -
Satisfaction 40 - -
Moderate 2 - -
Dissatisfaction 6 - -
Very Dissatisfaction 0 - -
Comparing final results (%)
So much effectiveness 34 - -
Much effectiveness 36 - -
Moderate 24 - -
Mild effectiveness 6 - -
very mild effectiveness 0 - -

Table of adverse events

There were no adverse events.

First publication date
2024-04-02, 1403/01/14
Abstract of published paper
This research aimed to fabricate a natural hybrid biomaterial and assess its physicochemical/biological properties to study the role of the therapeutic biomaterial in the growth of human monocytes, synoviocytes, chondrocytes, expression of type-I/II collagen, and osteogenic differentiation for bone tissue engineering applications, as well as to assess effects of bio-ointment derived from this biomaterial on relief of musculoskeletal pains. Hence, an oily formula [turmeric:ginger:chili pepper:rose oils (1:1:1:1w/w)] was mixed with the base oil [sesame:black seed:olive oils (1:0.4:0.6w/w)] in 3 wt ratios of 1:6(H1), 1.5:5.5(H2), and 2:5(H3). Accordingly, H2 indicated a better performance in cell growth and decrease of inflammatory mediators and led to the highest expression of osteoblastic genes of RUNX2, OCN, and OPN, as well as collagen I and II (COL1A1,COL2A) respectively 1.3-fold, 1.7-fold, and 1.4-fold, as well as %87 % and ∼ 60 % higher than H1, and ∼ 2-fold, 2.1-fold, and 3.4-fold, and ∼ 19 % and ∼ 16 % higher than H3. A clinical study on H2 was also performed on 50 patients with musculoskeletal pains. H2-based bio-ointment could relieve pain in less than 10 min for 40 % of patients and after 30 min from use for 35 %. Moreover, the analgesia period for 60 % and 36 % of patients lasted for longer than 3 h and between 2 h and 3 h, respectively. 76 % also stated that bio-ointment possesses stronger effects than other treatments along with moderate warming functions. Finally, although 6 % of patients reported mild effectiveness in pain relief, 92 % of users stated this therapeutic method has resulted in more effects on their pain relief and damaged organ performance recovery.
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