| CTRI Number |
CTRI/2018/12/016730 [Registered on: 19/12/2018] Trial Registered Prospectively |
| Last Modified On: |
27/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Hair growth after using Herbodaya hair oil |
|
Scientific Title of Study
|
A Randomized comparative clinical end point study to assess the Efficacy and safety of Herbodaya Bringa Hair oil and Shikaka Hair Wash in hair regrowth in male and female subjects with hair loss disorder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramesh Kannan |
| Designation |
Assistant Professor |
| Affiliation |
KI3, CRO |
| Address |
Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
Room no:10, Medicine OPD, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Vellore
TAMIL NADU
Dr Ramesh Kannan
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh Kannan |
| Designation |
Assistant Professor |
| Affiliation |
KI3, CRO |
| Address |
Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
Room no:10, Medicine OPD, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Vellore
TAMIL NADU
Dr Ramesh Kannan
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramesh Kannan |
| Designation |
Assistant Professor |
| Affiliation |
KI3, CRO |
| Address |
Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
Room no:10, Medicine OPD, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Vellore
TAMIL NADU
Dr Ramesh Kannan
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
|
Source of Monetary or Material Support
|
| SKM SIDDHA AND AYURVEDA COMPANY (INDIA) Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
SKM SIDDHA AND AYURVEDA COMPANY INDIA Pvt Ltd |
| Address |
Saminathapuram Post,
Modakkurichi - 638 104.
Erode District,TamilNadu,India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Kannan |
Madras Medical College, Chennai |
Room no:10, Medicine OPD, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Vellore
TAMIL NADU |
7708925866
srkguruvarshan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ki3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L648||Other androgenic alopecia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Herbodaya Bringa Hair oil: To take 5-10ml of the hair oil and gently apply & massage the oil daily at night for a period of 12 weeks |
1. Bhringaraj –prevents hairfall, strengthens roots, revives hair regrowth
2. Neeli –prevents greying, giving dark color to the hair
3. Alovera – acts as a coolant& moisturizer
4. Amala- rich source of vitamin C, has antioxidant properties
5. Hibiscus – reduces hairfall, acts as a hair conditioner
6. Vallari –ayurvedic nerve tonic, skin care herb, balances pitha.
7. Curry leaves –excellent source of iron; acts as a hair tonic
8. Ponnanganni –nourishes the scalp
9. Magandi –hair conditioner, colourant & coolant
10. Methi – rich source of iron, hair conditioner, balances pitha
11. Neem –prevents & cures dandruff and other scalp infections
12. Coconut oil –nourishes and strengthens hair follicles
13. Almond oil – vitalizes and gives shining to hair
14. Desi Cow’s milk – the protein ‘casein’ strengthens and nourishes hair
|
| Comparator Agent |
Indulekha bringha hair oil and Dhatri hair oil |
To take 5-10ml of the hair oil and gently apply & massage the oil daily at night for a period of 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with hair loss disorders such as telogen effluvium (as first line therapy), chronic female pattern hair loss, Androgenetic Alopecia (Stage I – IV)
2. Subjects who are willing to give written informed consent
|
|
| ExclusionCriteria |
| Details |
1.Androgenetic alopecia (Stage V and beyond)
2.Evidence of dermatological disease as revealed by history, physical
examination or laboratory assessment which may interfere with administration or assessment of study medication
3.Current use of dermatological drugs / preparations which may interfere with study evaluation.
4.Intolerance to any of ingredients of the formulation
5.Current alcohol or drug abuse
6.Subjects viewed by the investigator as not being able to complete the study.
7.Use of Hair product such as hair dyes, sprays, setting gels and restorers
8.Any procedures for hair enhancement and curling or straightening technique
9.Pregnant or breastfeeding women
10. Having abnormal thyroid profile.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in global photographic assessment for hair growth.
2. VAS- Visual analog scale.
3. Change in the investigator assessment score for Hair count in each
visit from enrollment onwards after treating with IP.
4. Subjective Assessment by the subjects using diary card
Evaluation technique.
5. Percentage of subjects responding to the therapy.
6. Acceptability of the treatment.
7. Global assessment for efficacy by Investigator and subjects.
|
AT 4 weeks, 8 weeks and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of adverse events measured |
4,8 and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/12/2018 |
| Date of Study Completion (India) |
21/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The subjects who fulfilled the inclusion and exclusion criteria will
be enrolled in the study
The selected subjects should be randomized for test and control
therapy. The Test arm 1 will receive Herbodaya Bringa Hair oil & Shikaka Hair Wash. The subjects will be asked to take 5-10ml of the hair oil
and gently apply & massage the oil daily for a period of 12 weeks. They
will be asked to apply the oil from the ends towards the roots of the hair
follicles, hair root, scalp and to the length of the hair. The oil will be
allowed to work on the scalp overnight. Herbodaya Shikaka hair wash will be
used to wash the hair twice a week for 12 weeks. The Reference arm 2 will receive Indulekha bringha hair oil. The
subjects will be asked to take 5-10ml and gently apply & massage the oil
daily for a period of 12 weeks. The Reference arm 3 will receive Dhatri hair
oil. The subjects will be asked to take 5-10ml and gently apply & massage
the oil daily for a period of 12 weeks. The primary and secondary outcome will be analyzed on 4th, 8th and 12th week. |