Hanzal or Bitter apple (Citrullus colocynthis) is used in Iranian traditional medicine to relieve pain. Recent researches have also shown its analgesic effect in animal studies. The objective of this study is to assess the effects of Hanzal oil on pain in painful diabetic neuropathy. In this study, 60 patients with painful diabetic neuropathy in the lower extremities who their severity of pain with visual analogue scale are more than 30 mm, and are taking routine treatments are included in the study after ruling out the other causes of neuropathy. Then they are randomly divided into two groups of 30 cases. One group receives local Hanzal oil 5 puffs twice a day (at least two hours after taking glucose-lowering drugs), and the other group receives placebo in the same way. Oral medications continue and topical pain killers discontinue. One and two months later, severity of pain will be assessed with visual analogue scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211151957N4
Registration date:2012-12-27, 1391/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-27, 1391/10/07
Registrant information
Name
Fataneh Hashem Dabaghian
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 3395 0152
Email address
fatanehdabaghian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Research Institute for Islamic and Complementary Medicine (Tehran University of Medical sciences)
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Citrullus colocynthis oil with placebo on pain in patients with painful diabetic neuropathy
Public title
Effect of Hanzal oil on pain of diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-80 years, type 2 diabetes mellitus, painful diabetic neuropathy, pain in lower limbs, rule out other causes of neuropathy, neuropathy for more than 6 months, severity of pain more than 3 mm in visual scale of pain, written informed consent, Exclusion criteria: glycosylated hemoglobin more than 10, taking insulin, sever acute pain that requires lidocaine, active or infected wounds in lower limbs, amputation of lower limbs, pregnancy, lactation
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be conducted by the table of random numbers. Color of oils and shape of containers of drug and placebo are similar. Blinding will be performed in patients, physician, and data analyzer.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institute for Islamic and Complementary Medicine (Tehran University of Medical sciences)
before intervention, 1 month and 2 months after intervention
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: Topical Hanzal oil 5 puffs twice daily on pain area. Hanzal oil has been made by traditional pharmacist in the Research Institute for Islamic and Complementary Medicine. To prepare hanzal oil, aquous extract of hanzal fruits was mixed and heated with twice its volume of sesame oil until the water evaporates and oil remains. Oil for 1 month consumption of each patient is placed in spray containers.
Category
Treatment - Drugs
2
Description
Topical paraffin oil 5 puffs twice daily on pain area. It is placed in spray containers for 1 month consumption of each patient.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center of Yazd
Full name of responsible person
Mohammad Afkhami
Street address
No. 12, Jomhuri eslami Blvd., Yazd, IRAN
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Islamic and Complementary Medicine (Tehran University of Medical sciences)