Protocol summary
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Study aim
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Oral intake of the herbal prebiotic "Triphala" may be effective in reducing scalp seborrhea.
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Design
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An 8-week randomized, patient- and outcome assessor-blinded, placebo-controlled intervention trial was conducted.
94 eligible patients were randomized into two groups.
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Settings and conduct
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trial was conducted from 2 June to 13 December 2015 at the dermatology clinic of the Skin and Stem Cell Research Center, Tehran, Iran. Participants were patients with scalp seborrhea aged 14 to 50 years.it was a randomized, patient- and outcome assessor-blinded, placebo-controlled intervention.Scalp sebum levels were analyzed using Sebumeter® sm 815.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: complaining of scalp oiliness, objectively confirmed by a trained physician. 14 to 50 years old
Exclusion criteria: any symptoms of seborrheic dermatitis, had used systemic corticosteroid, anti-fungal, isotretinoin, or contraceptive medications in the 4 weeks prior to the study, or had used topical corticosteroid or antifungal shampoos or solutions in the two weeks prior to the study. Patients with a history of autoimmune disease or any type of cancer and those who were pregnant or lactating were also excluded.
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Intervention groups
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8 weeks with twice a day capsules containing 1 g of the herbal combination Triphala (standardized as 234.2 mg polyphenols per 1 g Triphala) or a placebo (wheat flour).
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Main outcome variables
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changing in scalp sebum levels (μg/cm2)
General information
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Reason for update
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Correction of sample size and contact information
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2014070218332N1
Registration date:
2015-06-17, 1394/03/27
Registration timing:
registered_while_recruiting
Last update:
2019-10-26, 1398/08/04
Update count:
1
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Registration date
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2015-06-17, 1394/03/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice Chancellor for research, Shahid Sadoughei University of Medical Sciences
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Expected recruitment start date
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2015-06-02, 1394/03/12
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Expected recruitment end date
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2015-12-13, 1394/09/22
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Actual recruitment start date
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2015-06-02, 1394/03/12
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Actual recruitment end date
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2015-12-13, 1394/09/22
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Trial completion date
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2015-12-13, 1394/09/22
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Scientific title
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evaluation the efficacy of itrifal saghir on head sebum production in seborrheic patients reffering to dermatology clinic of tehran imam khomeiny hospital in comparison with placebo .
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Public title
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effect of itrifal saghir on scalp seborrhea
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
inclusion criteria:؛patients aged 14 to 50 years suffering from scalp seborrhea.
scalp oiliness was objectively confirmed by a trained physician.
Exclusion criteria:
pregnancy
breast feeding
patients with auto immune disease
patients with any kind of cancer
presence of seborrheic dermatitis sings on head
using oral and topical drugs for treating seborrhea from 4 and 2 weeks before joining the research.
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Age
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From 14 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
94
Actual sample size reached:
91
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A randomization sequence block was generated by computer using balanced block-of-four.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The generated random sequence was coded by anonymous codes so that the patient allocation process would be concealed into two groups. Due to the similarity of the inactive substance capsules in the case group, the patients remained unaware by their allocation to the treatment groups. Also the outcome assessor was not aware of groups' allocation.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2014-06-28, 1393/04/07
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Ethics committee reference number
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IR.SSU.REC.1393.65406
2
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Ethics committee
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Approval date
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2016-01-06, 1394/10/16
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Ethics committee reference number
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IR.TUMS.REC.1394.1574
Health conditions studied
1
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Description of health condition studied
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scalp seborrhea
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ICD-10 code
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L21.0
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ICD-10 code description
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seborrhoea capitis
Primary outcomes
1
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Description
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The sebum level of the scalp measured by sebumeter sm 815
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Timepoint
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0-week 4-week 8
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Method of measurement
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sebumeter sm 815- unit: μg/cm2
Secondary outcomes
1
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Description
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Participants' overall satisfaction with the treatment process was rated at the end of the study on a scale from 0=very poor to 100=very good.
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Timepoint
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At the end of the study
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Method of measurement
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It was rated on a scale from 0=very poor to 100=very good.
Intervention groups
1
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Description
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Placebo:wheat flour.Filled in 1 gr capsules.8 weeks
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Category
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Treatment - Drugs
2
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Description
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drug:Triphala.Filled in 1gr capsules.8 weeks
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Sadoughei University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Information about the main outcome can be shared after Unrecognizabling
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When the data will become available and for how long
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After printing the results in paper form
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To whom data/document is available
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Researchers working in academic institutions
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Under which criteria data/document could be used
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Analysis similar to that used in the paper or supplement
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From where data/document is obtainable
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Elham Zareie
zareiehms1@gmail.com
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What processes are involved for a request to access data/document
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After considering no contradiction with research ethics for up to 3 months
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Comments
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