| CTRI Number |
CTRI/2023/02/049425 [Registered on: 03/02/2023] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To check the effect of oil on hair growth and dandruff. |
|
Scientific Title of Study
|
An Open label, Clinical Safety and Efficacy Study for evaluation of Hair oil in reduction in hair
fall, reduction in dandruff and hair growth in healthy adult subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TG/CLI/066(1.0 & Dated 17 Jan 2023 ) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B Sohandas Shetty |
| Designation |
Principal Investigator |
| Affiliation |
Trial Guna Pvt Ltd |
| Address |
TrialGuna Pvt Ltd
# 467,1st Main, 4th Cross, Royal County
Layout, JP Nagar 8 th Phase, 2 nd block, Bangalore 560083
Bangalore
KARNATAKA
560083
India |
| Phone |
8867125414 |
| Fax |
|
| Email |
drsohanshetty@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Sohandas Shetty |
| Designation |
Principal Investigator |
| Affiliation |
Trial Guna Pvt Ltd |
| Address |
TrialGuna Pvt Ltd
# 467,1st Main, 4th Cross, Royal County
Layout, JP Nagar 8 th Phase, 2 nd block, Bangalore 560083
KARNATAKA
560083
India |
| Phone |
8867125414 |
| Fax |
|
| Email |
drsohanshetty@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
CRO Representative |
| Affiliation |
Trial Guna Pvt Ltd |
| Address |
467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
9972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
| Buy happy Marketing LLP
Prince info perk, No. 81 B, 2nd floor, Tower B, 2nd Main,
Sai Nagar, Ambattur Industrial estate, Chennai, Tamil
Nadu |
|
|
Primary Sponsor
|
| Name |
Buy happy Marketing LLP |
| Address |
Prince info perk, No. 81 B, 2nd floor, Tower B, 2nd Main,
Sai Nagar, Ambattur Industrial estate, Chennai, Tamil
Nadu |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Sohandas Shetty |
TrialGuna Private Limited |
467,2nd floor, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA |
8867125414
drsohanshetty@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L659||Nonscarring hair loss, unspecified. Ayurveda Condition: KESAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Dhayani Herbal Hair oil, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(NA), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -Coconut oil, curry leaves , amla |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with Hair loss problems,mild to moderate dandruff and thinning of hair.
2. Healthy Adult Volunteers of ≥18 to ≤ 50 years inclusive of both genders
3. Subjects generally in good health and willing to give written
informed consent and willing to follow the study procedure will be enrolled in the study
4. Subjects with hair all count of 40-50 for females and 25-30 for males as evaluated by 60secs comb test .
|
|
| ExclusionCriteria |
| Details |
1.History of any dermatological conditions of the scalp (other than dandruff or seborrheic dermatitis or hair loss) that would interfere with the diagnosis or assessment (e.g. psoriasis,
eczema, atopic dermatitis, or other skin/scalp infections).
2. Subjects with excessive erythema, crusting or a significant
number of pustules/papules on the scalp.
3. History ofskin cancer or treatment for any type of cancer within the last 2 years.
4. History of prior use of antidandruff treatment on scalp within past 1 month.
5. Participation in a similar clinical study within the previous 90 Days.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Evaluate the efficacy of the product for reducing hair fall.
2. Safety of the product in the treatment of dandruff.
3. Evaluating the efficacy and safety of product on increasing the hair growth or reducing the thinning of Hair |
Baseline,Day 14,Day 30,Day 60 |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
06/02/2023 |
| Date of Study Completion (India) |
23/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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)?
Response - NO
|
|
Brief Summary
|
An Open label, Clinical Safety and Efficacy Study for evaluation of
Hair oil in reduction in hair fall, reduction in dandruff and hair growt
in healthy adult subjects.This is an open label, clinical study to evaluate efficacy and safety of hair oil in subjects with hair
fall, dandruff, and hair loss.
The potential subjects will be screened as per the inclusion and exclusion criteria only after
obtaining written informed consent from the subjects.
Study visits will consist of a screening and enrollment visit, evaluation follow up visits at day at
day 14 (± 1 day), day30 (± 1 day), and day 60(± 1 day) end of study visits. |