A randomized clinical trial of topical effect of Nigella sativa oil, on the symptoms of peripheral neuropathy induced by chemotherapy in cancer patients
The objective of this trial was to evaluate the effect of Nigella sativa oil to improve symptoms caused by chemotherapy in patients with cancer. For this purpose, 70 cancer patients older than 16 years that In the last 6 months have been undergoing chemotherapy with neuropathic symptoms Placed on trial, Assuming that patients are without diabetes. This patient devided in 2 groups. In a group of drugs prescribed by Nigella sativa oil and paraffin oil as a placebo group given. Patients should oil twice daily topical over the wrist or leg down and gently massage the treated. Each of the patients who are treated unforeseen or worsening of the disease have been excluded, And severity of symptoms and quality assessment questionnaire and a 6-week observation period specified, Refer patients every two weeks and completed the questionnaires filled. At the end of treatment in terms of changes in sensorimotor collected and examined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092419182N1
Registration date:2015-02-23, 1393/12/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-23, 1393/12/04
Registrant information
Name
Mehdi Fallah
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
dr_fallah@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized clinical trial of topical effect of Nigella sativa oil, on the symptoms of peripheral neuropathy induced by chemotherapy in cancer patients
Public title
Effect of Nigella sativa oil on chemotherapy-induced neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the risk of cancer; chemotherapy in the last 3 months ; the signs of peripheral neuropathy ; non-diabetes ; Minimum age 16 years , a willingness to cooperate in the design ; Psychological and mental health.
Exclusion Criteria: unwillingness to continue the study; acute psychological symptoms such as depression, Unforeseen treatment such as radiotherapy ; signs of autonomic nervous system dysfunction ; any signs or symptoms of allergy caused by medication ; the patients' illness
Age
From 16 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee martyr Beheshti University of Medical Sciences
Street address
Vali Asr Ave. against tavanir Alley Shams
City
Tehran
Postal code
Approval date
2013-12-29, 1392/10/08
Ethics committee reference number
400/6408
Health conditions studied
1
Description of health condition studied
Chemotherapy-induced neuropathy
ICD-10 code
G62.2
ICD-10 code description
Polyneuropathy due to other toxic agents
Primary outcomes
1
Description
Symptoms of neuropathy
Timepoint
Weeks of the second, fourth and sixth from baseline
Method of measurement
Questionnaire
Secondary outcomes
1
Description
skin allergy
Timepoint
Second, fourth and sixth weeks of baseline
Method of measurement
questionnaire
Intervention groups
1
Description
Nigella sativa oil is used topically on the affected limb twice a day for 6 weeks
Category
Treatment - Drugs
2
Description
The use of paraffin oil as a placebo twice daily for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department Of Oncology, Shohada Hospital
Full name of responsible person
Mehdi Fallah
Street address
Tajrish Square, Valiasr St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes
Full name of responsible person
Rasool Choopani M.D, Ph.D, Assistant Professor
Street address
No.8 Shams Alley, opposite St tavanir, Vali Asr Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh
Full name of responsible person
Dr. Mehdi Fallah
Position
PHD Assistant traditional medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Vali Asr Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 6029
Fax
Email
dr_fallah@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh
Full name of responsible person
Dr. Mehdi Fallah
Position
ph.D student ofTraditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Vali Asr Street, Tehran
City
Teran
Postal code
Phone
+98 21 8877 6029
Fax
Email
dr_fallah@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh
Full name of responsible person
Mehdi Fallah
Position
ph.D student ofTraditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Vali Asr Street
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
+98 21 8877 6027
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)