| CTRI Number |
CTRI/2019/11/021941 [Registered on: 11/11/2019] Trial Registered Prospectively |
| Last Modified On: |
30/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study how Effective and Safe is the Stretch Mark Oil and Stretch Mark Cream in Prevention and Reduction of Stretch Marks in Pregnant Women and Post-delivery Women |
|
Scientific Title of Study
|
An Open Label, Parallel Two Group Clinical Study to Evaluate the Efficacy and Safety of Stretch Mark Oil and Stretch Mark Cream in Prevention and Reduction of Stretch Marks in Pregnant Women and Post- Partum Women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BIAG-CSP-029. version1.0 03Sep2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kamini A Rao |
| Designation |
Consultant Gyneacologist |
| Affiliation |
Milann The Fertility Center - A unit of IIHR -BACC Healthcare Pvt Ltd. |
| Address |
Milann The Fertility Center - A unit of IIHR -BACC Healthcare Pvt Ltd.
#3, East park Road, Kumara Park East, Bangalore
Bangalore
KARNATAKA
560001
India |
| Phone |
9620220960 |
| Fax |
|
| Email |
drkaminirao@milann.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalini Dayananada |
| Designation |
Associate Vice President |
| Affiliation |
BioAgile Therapeutics Pvt Ltd |
| Address |
BioAgile Therapeutics Pvt Ltd
#2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage,, Bengaluru, Karnataka 560094
Bangalore
KARNATAKA
560094
India |
| Phone |
08043754520 |
| Fax |
|
| Email |
pm@bioagiletherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya C |
| Designation |
Director |
| Affiliation |
Bio Agile Therapeutics Pvt. Ltd |
| Address |
BioAgile Therapeutics Pvt Ltd
#2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage,, Bengaluru, Karnataka 560094
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug Company, Bangalore |
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
Makali, Bangalore |
| 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 Kamini A Rao |
Milann - The Fertility Center - BACC Healthcare Pvt Ltd |
Department of Gyneacology
#7, East Park Road, Kumara Park East.
Bangalore
KARNATAKA |
080-22011311
drkaminirao@milann.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IIRRH-BACC Healthcare Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stretchmarks due to preganancy - Ante partum and Post Partum |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Stretch Mark Oil and Stretch Mark Cream |
Take sufficient quantity up to 5ml of oil /cream and apply gently on the stretch marks prone area (Group-I - preventive) and on the stretch marks area until delivery and 3months post delivery (Group-I -treatment) / on the stretch marks area (Group II-treatment) twice daily on abdomen area for 3months.
Post-partum subjects who have undergone C-section should avoid applying the test product on the incision line and should apply the product on the rest of the abdomen area. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Aged ≥ 18 years at recruitment.
Primigravid women.
Singleton pregnancy.
Women with one of the following:
Pregnant women between 12–14 weeks of gestation with absence of abdominal striae (for Group I).
Post-Partum women with normal and C-section delivery and visible stretch marks (will be enrolled at the time of discharge- Post-partum - Group-II)
Willing to participate and continue with the study follow-ups.
|
|
| ExclusionCriteria |
| Details |
Multigravida women (due to risk of having striae from an earlier pregnancy) or with already existing striae from earlier weight loss or any other reasons.
Women taking corticosteroids for any reason (due to their association with skin striae).
High risk pregnancy.
Bad obstetric history.
Any risk/ infection known to develop congenital anomaly in the baby (TORCH infections).
Multiple pregnancies (due to increased maternal weight gain and skin stretching).
Women with a known hypersensitivity to agents in formulation (due to risk of allergic reaction).
Women with known disorders or illnesses that maybe associated with striae, e.g. Marfan syndrome, Cushing syndrome.
Women who decline to discontinue other creams or lotions.
Women who are unable to give informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Appearance of striae
Visible changes/improvement in the stretch marks, (including the severity, and, color).
Changes /improvement in relief of associated symptoms such as dryness, itching, moisturization and skin texture by using VAS scale
Evaluation for reduction/treatment of stretch marks (including the severity and color) post-delivery the stretch marks
Improvement in skin elasticity and firmness of skin by Elastimeter. |
visit 1, visit 2, visit 4, and visit 6, at the time of discharge, visit 8 and visit 9. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prevention of visible appearance of stretch marks during the pregnancy (starting the application from13thweek (± 1 week) of pregnancy).
Relief of associated symptom such as dryness and itchiness during pregnancy and post-partum.
Monitor any adverse events.
|
visit 1, visit 2, visit 4, and visit 6, at the time of discharge, visit 8 and visit 9. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/11/2019 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Stretch marks (striae) are skin lesions present in
numerous physiological and pathological conditions. Based on lesions etiology,
many types can be distinguished and the most common ones are striae gravidarum.
Striae gravidarum are common during the first
Pregnancy and usually present during the third trimester. Prevalence of Striae
gravidarum in women is 43% and usually develops prior to 24 weeks of gestation;
however prevalence may ranges from 50 to 90% depending on the population.
Striae usually start as reddish and then slightly depressed streaks and fade
gradually to leave pale wrinkled lines which will be permanent skin changes.Current research on risk factors, prevention, and
management of this condition has been limited or met with little success and/or
provided conflicting results. Considering the unmet need, Himalaya has developed
Stretch Mark Oil and Stretch Mark Cream with natural ingredients for pregnant
women and Post- Partum women. It is expected to help to reduce the appearance
and severity of the signs and symptoms associated with stretch marks during and
after the pregnancy without having any harmful effects. |