| CTRI Number |
CTRI/2014/07/004796 [Registered on: 31/07/2014] Trial Registered Retrospectively |
| Last Modified On: |
31/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the efficacy and safety of mukulpure in treating the acne. |
|
Scientific Title of Study
|
A Prospective, Randomized, Double blind, Placebo controlled clinical trial to evaluate efficacy and safety of MUKUL PURE in treating Acne |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/VH/1226/33 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Prasad |
| Designation |
Consultant Dermatologist |
| Affiliation |
Revive Cosmetic Clinic |
| Address |
Revive Cosmetic Clinic No.72, 2nd Road, Nandidurga Extn, Jayamahal Bangalore 560 046
Bangalore
KARNATAKA
560046
India |
| Phone |
9844061806 |
| Fax |
|
| Email |
revive_cos@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harisha S |
| Designation |
Director-Operations |
| Affiliation |
ICBio Clinical research Pvt Ltd |
| Address |
ICBio Clinical Research Pvt. Ltd. #16, ICBio Tower, Yelahanka Main Road Chikkabetahalli, Vidyaranyapura,Bangalore
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harisha S |
| Designation |
Director-Operations |
| Affiliation |
ICBio Clinical research Pvt Ltd |
| Address |
ICBio Clinical Research Pvt. Ltd. #16, ICBio Tower, Yelahanka Main Road Chikkabetahalli, Vidyaranyapura,Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VIdya Herbs |
| Address |
#30,33 Main JP nagar,6 Phase ,Bangalore-560078,India |
| Type of Sponsor |
Other [Herbal Company] |
|
|
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 J Prasad |
Revive Cosmetic Clinic |
#72, 2nd Road, Nandidurga Extn, Jayamahal Bangalore – 560 046
Bangalore
KARNATAKA |
9844061806
revive_cos@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical IEC Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Facial acne |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MUKUL PURE capsules |
Two times a day before breakfast and dinner for 90 days taken orally |
| Comparator Agent |
Placebo Capsules |
Two times a day before breakfast and dinner for 90 days taken orally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
• Both Male / Female of age between 18-50 yrs
• Facial acne, with:
1. Inflammatory facial lesions (papules/pustules/nodules/cysts)
2. Non inflammatory facial lesions if open (blackhead) and if closed (whitehead) comedones
3. Mild to moderate acne with nodular abcesses, extensive lesions
• Willing to give written informed consent along with audio, video recording
|
|
| ExclusionCriteria |
| Details |
• Patient not willing to comply with the study procedure
• Females who are pregnant or breast-feeding
• Skin diseases other than acne vulgaris
• Use of other topical or systemic treatments for acne
• Other significant medical conditions or clinically significant abnormal laboratory test results
• History of alcoholism or substance abuse and any other liver abnormalities
• Conditions in the opinion of the investigator make the patient unsuitable to participate in the study.
• History of Hormone-sensitive condition such as breast cancer, uterine cancer, ovarian cancer, endometriosis, or uterine fibroids
• Patients under medication with contraceptive pills, Diltiazem, Anticoagulant and Propranolol.
• History of hypothyroidism or hyperthyroidism
• History of HIV
• Participation in another trial within 3 months prior to informed consent
• Certain medications that may interfere with the study medication (these will be identified by the study doctor).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Percent reduction in inflammatory Acne lesion counts (Baseline to EOT)
• Reduction in white and black heads (Baseline to EOT)
• Changes in blood investigations
|
Screening to day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Investigators overall assessment of facial acne using Four-point scale ranging from ‘excellent’ to ‘poor’ response Investigator Global Assessment (IGA) (appendeix-1)
• Subject QOL Questionnaire
• No. of adverse events captured.
|
Screening to day 90 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
17/06/2014 |
| Date of Study Completion (India) |
24/09/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A
Prospective, Randomized, Double blind, Placebo controlled clinical trial to
evaluate efficacy and safety of MUKUL PURE in treating Acne. |