| CTRI Number |
CTRI/2022/07/044013 [Registered on: 14/07/2022] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Anti-acne spot oil in pimples |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of Anti-acne Spot Oil in participants suffering from Acne Vulgaris- An open label, non-comparative, interventional, prospective, clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ACNEOIL/NAMSKARAYU/2022/1, Version 2.0, 07th June 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mule Smita Dinkar |
| Designation |
Assistant Professor |
| Affiliation |
Late Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur |
| Address |
Department of Panchakarma, OPD No 10, 1st Floor, Late Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur, Behind Bus Stand, Gandhi Maidan, Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9423734839 |
| Fax |
|
| Email |
smitadinkar2811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A Wing 402- A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A Wing 402- A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Namaskar Ayurved Private Limited,
Unit - 4, Ground Floor,Peninsula Chambers
Peninsula Corp Park G K Marg Lower Parel
Mumbai-400013
|
|
|
Primary Sponsor
|
| Name |
Namaskar Ayurved Private Limited |
| Address |
Unit - 4, Ground Floor,Peninsula Chambers
Peninsula Corp Park G K Marg Lower Parel
Mumbai-400013
|
| 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 Mule Smita Dinkar |
Late Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur |
Department of Panchakarma, OPD No 10, 1st Floor, Late Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur, Behind Bus Stand, Gandhi Maidan, Latur – 413512.
Latur
MAHARASHTRA |
9423734839
smitadinkar2811@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Anti-acne spot oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Subjects will be asked to apply Anti-acne Spot Oil on acne lesions twice daily for a period of 30 days. Subjects will be advised to retain Anti-acne Spot Oil on face |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects suffering from acne vulgaris [mild and moderate as per Global Acne Grading System (GAGS)] as diagnosed by physician or dermatologist
2. Subjects willing to follow study instructions given by the investigator
|
|
| ExclusionCriteria |
| Details |
1. Subjects with known pre-existing systemic disease necessitating long-term medications.
2. Subjects with known current endocrinal disorders.
3. Subjects taking treatment for menstrual disorders
4. Subjects having systemic treatment for acne vulgaris.
5. Subjects on any other investigational products within 1 month prior to randomization;
6. Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure.
7. Pregnant and lactating women
8. Known hypersensitivity to any of the ingredients of Anti-acne Spot Oil
9. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in total number of inflammatory acne lesions on face |
Screening / Baseline visit (Day 0), Visit 1 (24 hrs. post skin patch test application), Visit 2 (48 hrs. post skin patch test application) visit 3 (Day 15), visit 4 (Day 30) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in total numbers of non-inflammatory acne lesions
2. Changes in total lesion count (inflammatory and non-inflammatory)
3. Difference in number of comedones (blackheads and whiteheads)
4. Changes in severity of acne vulgaris
5. Changes in signs and symptoms
6. Changes in acne scarring
7. Changes in post acne dark spots
8. Assessment of 24 hr skin patch test
9. Assessment of ability of Anti-acne Spot Oil to absorb into the skin
10. Assessment of oily/greasy appearance of skin after application of oil
11. Assessment of feeling of oil on skin
12. Global assessment for overall change by participants and by physician
13. Assessment of post treatment tolerability of study drug by participants and physician.
14. Assessment of adverse events/adverse drug reactions including vitals
|
Screening / Baseline visit (Day 0), Visit 1 (24 hrs. post skin patch test application), Visit 2 (48 hrs. post skin patch test application) visit 3 (Day 15), visit 4 (Day 30) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/07/2022 |
| Date of Study Completion (India) |
22/09/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is an open label, non-comparative, interventional, prospective, clinical study to evaluate efficacy and safety of Anti-acne spot oil in participants suffering from Acne Vulgaris. Subjects will be asked to apply Anti-acne Spot Oil on acne lesions twice daily for a period of 30 days. Subjects will be advised to retain Anti-acne Spot Oil on face. The primary objective of the study will be to assess changes in total number of inflammatory acne lesions on face. The secondary objectives of the study will be to assess total numbers of non-inflammatory acne lesions, total lesion count (inflammatory and non-inflammatory), difference in number of comedones (blackheads and whiteheads), severity of acne vulgaris, signs and symptoms, acne scarring, post acne dark spots, 24 hr skin patch test, ability of Anti-acne Spot Oil to absorb into the skin, oily/greasy appearance of skin after application of oil, feeling of oil on skin, global assessment for overall change by participants and by physician, post treatment tolerability of study drug by participants and physician and adverse events/adverse drug reactions including vitals on screening / baseline visit (Day 0), Visit 1 (24 hrs. post skin patch test application), Visit 2 (48 hrs. post skin patch test application) visit 3 (Day 15), visit 4 (Day 30) Results and Conclusion: Namaskar Ayurved Anti-acne spot oil was
effective in significantly reducing inflammatory, non-inflammatory acne
lesions, comedones (blackheads and
whiteheads), symptoms of acne vulgaris including pain, edema, erythema,
burning, post acne dark spot, acne scarring and severity of acne vulgaris.
Namaskar Ayurved Anti-acne spot oil was found to be safe in subjects for
regular use. |