Protocol summary

Study aim
Investigating the effectiveness of herbal hair growth stimulating solution compared to minoxidil solution and evaluating herbal cream, mask and soap in the treatment of skin spots
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized
Settings and conduct
This study is conducted in Razi University. On days 0, 3, 7, 14, 21 and 28, the hair density and the overall satisfaction of the patient and the blind researcher with the overall hair growth are measured.
Participants/Inclusion and exclusion criteria
Based on the calculated sample size, a number of women and men between the ages of 18-70 with one of the following problems: hair loss, baldness, low density of hair, damaged hair or skin spots are included in the study. Pregnant and lactating patients and suffering from chronic and acute kidney, liver, heart, vascular and pulmonary diseases are excluded from the study.
Intervention groups
Patients are divided into 7 categories: hair tonic, shampoo, eyebrow tonic, revitalizing tonic, mask, cream, and soap, and each category is divided into three groups. Hair tonic category into three groups: herbal hair growth tonic, minoxidil and Shahid, shampoo category into three groups: herbal hair growth stimulating shampoo, minoxidil and Shahid shampoo, eyebrow tonic category into three groups: herbal eyebrow growth tonic, eyelash enhancer And Abru Mavala and Shahid, revitalizing tonic category into three groups: herbal hair revitalizing tonic, Vasu and Shahid hair revitalizing serum, cream category into three groups: herbal cream, alpha hydroxy acid cream and Shahid, mask category into three groups: mask Herbal, Lexion and Shahid face lifting mask, the soap category is divided into three groups: Herbal soap, Lilac brightening pen and Shahid.
Main outcome variables
Hair density, hair growth, headache, itching

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240402061400N2
Registration date: 2024-06-29, 1403/04/09
Registration timing: registered_while_recruiting

Last update: 2024-06-29, 1403/04/09
Update count: 0
Registration date
2024-06-29, 1403/04/09
Registrant information
Name
Nasim Batooie
Name of organization / entity
Razi University
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 0181
Email address
nasim.batooie90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effectiveness of herbal hair growth stimulating solution with minoxidil solution in the treatment of hair loss and evaluation of the anti-blemish effect of herbal cream, mask and soap in the treatment of skin blemish
Public title
Investigating the effectiveness of herbal cosmetic products (hair growth stimulating tonic, eyebrow growth stimulating tonic, hair growth stimulating shampoo, damaged hair revitalizing tonic, cream, face mask and soap) on hair growth and skin rejuvenation and introducing new formulations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signing a written consent to participate in the study Age between 18-70 years In the categories of hair growth stimulating tonic and hair growth stimulating shampoo: patients must face at least one of the problems: hair loss, baldness or low density of hair. In the category of eyebrow growth stimulating tonic: patients must face at least one of the following problems: eyebrow loss and low density of eyebrows. In the category of hair regenerating tonic: patients must face the problem of damaged hair or hair with frizz. In the categories of creams, masks and soaps: patients must have at least one of the following problems: skin spots, wrinkles on the skin, or darkening of the skin.
Exclusion criteria:
pregnancy breastfeeding History of using anabolic steroids in the last 6 months History of using minoxidil 2% to 5% in the form of solution or foam or shampoo in the last 6 months History of using finasteride and anti-androgen drugs in the last 6 months History of taking drugs that cause hypertrichosis such as cyclosporine, systemic corticosteroids in the last 6 months Suffering from chronic and acute kidney, liver, heart, vascular and pulmonary diseases
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 420
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient is given a three-digit code (001, 002, 003, ..., 420) and then, using a table of random numbers, 420 patients are divided into 21 groups of 20 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients, the doctor who prescribes the medicine, the person responsible for collecting the data, the researcher who gives an opinion about the growth, the one who evaluates the results and the one who analyzes the data do not know the type of medicine.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Razi University
Street address
Zakariai Razi Blvd., Taq-e Bostan
City
kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2023-11-11, 1402/08/20
Ethics committee reference number
IR.RAZI.REC.1402.098

Health conditions studied

1

Description of health condition studied
Nonscarring hair loss
ICD-10 code
L65.9
ICD-10 code description
Alopecia NOS

2

Description of health condition studied
skin blemish
ICD-10 code
L81.4
ICD-10 code description
Other melanin hyperpigmentation

Primary outcomes

1

Description
hair density
Timepoint
At the beginning of the study (before the start of the intervention) and 7, 14, 21 and 28 days after the start of the study
Method of measurement
Digital image and view

2

Description
Patient satisfaction
Timepoint
7, 14, 21 and 28 days after the start of the study
Method of measurement
questionnaire

3

Description
Hair regrowth based on doctor's opinion
Timepoint
7, 14, 21 and 28 days after the start of the study
Method of measurement
Digital image and view

4

Description
Size and number of skin spots
Timepoint
At the beginning of the study (before the start of the intervention) and 7, 14, 21 and 28 days after the start of the study
Method of measurement
Digital image and view

Secondary outcomes

1

Description
hair growthHeadache
Timepoint
At the beginning of the study (before the start of the intervention) and 7, 14, 21 and 28 days after the start of the study
Method of measurement
Ask the patient

2

Description
itching
Timepoint
At the beginning of the study (before the start of the intervention) and 7, 14, 21 and 28 days after the start of the study
Method of measurement
Ask the patient

3

Description
Erythema-redness
Timepoint
At the beginning of the study (before the start of the intervention) and 7, 14, 21 and 28 days after the start of the study
Method of measurement
Ask the patient

Intervention groups

1

Description
Intervention group in the shampoo group: 15 cc of minoxidil laminin shampoo between two days for 28 days.
Category
Treatment - Drugs

2

Description
Intervention group in the shampoo group: 15 cc of herbal hair growth stimulating shampoo for 28 days between two days.
Category
Treatment - Drugs

3

Description
Control group in the shampoo category: two days in between, the amount of 15 cc of placebo for 28 days
Category
Placebo

4

Description
Intervention group in the category of eyebrow tonic: three times a day, two drops of Mavala eyelash and eyebrow enhancer for 28 days.
Category
Treatment - Drugs

5

Description
Intervention group in the category of eyebrow tonic: three times a day, two drops of herbal eyebrow growth stimulating tonic for 28 days.
Category
Treatment - Drugs

6

Description
Control group in eyebrow tonic category: two drops of placebo three times a day for 28 days
Category
Placebo

7

Description
Intervention group in the cream category: 2 times a day, 1 gram of Eucerin Roughness Relief Spot for 28 days
Category
Treatment - Drugs

8

Description
Intervention group in the cream category: two times a day, one gram of herbal cream for 28 days
Category
Treatment - Drugs

9

Description
Control group in the cream group: 1 gram of placebo twice a day for 28 days
Category
Placebo

10

Description
Intervention group in the mask group: 3 gram of Lexion face lifting mask once a day for 28 days.
Category
Treatment - Drugs

11

Description
Intervention group in mask group: 3gram of herbal face mask once a day for 28 days
Category
Treatment - Drugs

12

Description
Control group in the mask group: 3 gram of placebo once a day for 28 days
Category
Placebo

13

Description
Intervention group in the soap category: use the lilac lightening pen twice a day, morning and night, for 28 days
Category
Treatment - Drugs

14

Description
Intervention group in the soap group: use herbal soap twice a day, morning and night, for 28 days
Category
Treatment - Drugs

15

Description
Control group in the soap group: Placebo was used twice a day, morning and night for 28 days
Category
Placebo

16

Description
Intervention group in the hair rejuvenating category: three times a day, the amount of 6 cc of Vaso hair rejuvenating and strengthening serum for 28 days.
Category
Treatment - Drugs

17

Description
Intervention group in the hair rejuvenating category: three times a day, the amount of 6 cc of herbal regenerating tonic for 28 days.
Category
Treatment - Drugs

18

Description
Control group of the hair regenerating group: three times a day, the amount of 6 cc of placebo for 28 days
Category
Placebo

19

Description
Intervention group in the hair tonic category: twice a day, one milliliter of 2% minoxidil topical solution for 28 days.
Category
Treatment - Drugs

20

Description
Intervention group in the hair tonic category: twice a day, one milliliter of herbal hair growth stimulating solution for 28 days.
Category
Treatment - Drugs

21

Description
Control group in the hair tonic group: twice a day, one milliliter of placebo for 28 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi University
Full name of responsible person
Naim Batooie
Street address
Zakariai Razi Blvd., Taq-e Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
nasim.batooie90@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University Vice president of Research and Technology
Full name of responsible person
Nasim Batooie
Street address
Zakariai Razi Blvd., Taq-e Bostan
City
Kermanshsh
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 0181
Email
nasim.batooie90@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University Vice president of Research and Technology
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
Razi University
Full name of responsible person
Nasim Batooie
Position
Non-faculty researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Zakariai Razi Blvd., Taq-e Bostan
City
Kermanshsh
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 0181
Email
nasim.batooie90@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University
Full name of responsible person
Nasim Batooie
Position
Non-faculty researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Zakariai Razi Blvd., Taq-e Bostan
City
Kermanshsh
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 0181
Email
nasim.batooie90@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Razi University
Full name of responsible person
Nasim Batooie
Position
Non-faculty researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Zakariai Razi Blvd., Taq-e Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 0181
Email
nasim.batooie90@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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