| CTRI Number |
CTRI/2024/07/070726 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Herbal Face Pack on Acne vulgaris |
|
Scientific Title of Study
|
Effect of Herbal Face Pack on Acne vulgaris among young adult females – A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Konsam Sanjita |
| Designation |
MD Scholar |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Alvas College of Naturopathy and Yogic Sciences Room Number 9
Department of Clinical Naturopathy Moodbidre Mangalore Taluk
Dakshina Kannada
KARNATAKA
574225
India
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9108791093 |
| Fax |
|
| Email |
sanjitakonz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmeeesha D R |
| Designation |
Associate Professor, Guide |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Alvas College of Naturopathy and Yogic Sciences Room Number 9
Department of Clinical Naturopathy Moodbidre Mangalore Taluk
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9741735734 |
| Fax |
|
| Email |
dr.lakshmeesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajna |
| Designation |
Associate Professor, Co-Guide |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Alvas College of Naturopathy and Yogic Sciences Room Number 9
Department of Clinical Naturopathy Moodbidre Mangalore Taluk
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8151824315 |
| Fax |
|
| Email |
prajnamruth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas College of naturopathy and yogic sciences, Tenkamijar, Shobavana campus, Moodbidiri, Dakshina kannada, 574225 |
|
|
Primary Sponsor
|
| Name |
Dr Konsam Sanjita |
| Address |
Alvas College of naturopathy and yogic sciences, Tenkamijar,
Shobavana campus, Moodbidiri, Dakshina Kannada, 574225
|
| Type of Sponsor |
Other [Self sponser] |
|
|
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 Konsam Sanjita |
Alvas College of Naturopathy and Yogic Sciences |
Room Number 03
Department of Clinical
Naturopathy Alvas
College of Naturopathy
and Yogic Sciences
Mijar Moodbidre
Dakshina Kannada
Dakshina Kannada
KARNATAKA |
9108791093
sanjitakonz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE FOR HUMAN STUDIES OF ALVAS COLLEGE OF NATUROPATHY AND YOGIC SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
under standard medical care |
| Intervention |
herbal face pack |
herbal face pack combination of turmeric, sandalwood and neem pack for 20 minutes once a day duration 30 days
5g of sandalwood and turmeric and 2g of neem mixed with lukewarm water |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Facial acne with white heads, black heads, papules and pustules |
|
| ExclusionCriteria |
| Details |
1 Taking herbal medicine for acne for last 6 months.
2 Taking allopathic medicine for acne for last 6 months.
3 Subject known case of PCOD.
4 Subject having cystic acne.
5 Subject having allergic conditions like skin irritation, redness, itching on turmeric, sandalwood and neem.
6 Subject who participated in other clinical trials in the last 6 months
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Acne - specific Quality of life questioner (Acne - Qol)
Global acne grading system |
after 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dermatology life quality index (DLQI) |
after 30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit and associated with serious consequences such as scar formation and high psychological impact.
- Acne vulgaris has been affecting more than 85% of young individuals worldwide, usually manifests during puberty and worsens throughout adolescence, epidemiology studies suggested that it can occur at any age.
- According to naturopathy, skin problems are normally due to accumulation of toxins. so, herbal pack has been used as natural remedies for treatment of acne.
- The study will be conducted in an outpatient hospital setup. Participants will be screened after fulfilling inclusion and diagnostic criteria a total of 60 participants will be recruited for the study. The will be randomly divided into 2 equal groups. Study group n = 30 and control group n = 30. Pre - assessments will be recorded for both groups. Group A will be undergoing turmeric, sandalwood and neem pack for 25 minutes daily for 30 days. Group B will be under standard medical care. Post assessments will be recorded after the completion of 30 days.
- Post assessments will be done through Dermatology life quality index (DLQL), Global acne grading scale (GAGS), and Acne - specific Quality of life questioner (Acne - QoL) Questioner.
|