| CTRI Number |
CTRI/2022/11/047646 [Registered on: 24/11/2022] Trial Registered Prospectively |
| Last Modified On: |
18/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study on Nourishing Baby Massage oil in Newborn children |
|
Scientific Title of Study
|
Efficacy and safety of Nourishing Baby Massage oil in growth, development, muscle strength and behavioral assessment of Neonates - An open labeled, randomized, multi-centric, comparative, prospective, clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BBYOIL/MARICO/2022/1, Version 1.0, 11th OCT 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandip K Birari |
| Designation |
Assistant Professor |
| Affiliation |
KVTR Ayurved College and Hospital Boradi |
| Address |
Department of Kriya Sharir, OPD No 6, Ground Floor, KVTR Ayurved College and Hospital Boradi, Tal. Shirpur, Dist Dhule.
Dhule
MAHARASHTRA
425428
India |
| Phone |
9404582991 |
| Fax |
|
| Email |
sandipbirari@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
|
| Marico Ltd.
Plot No: 23/C, Mahal Industrial Estate,
Near Ahura Centre, Paper Box Gali,
Mahakali Caves Road, Andheri (E),
Mumbai-400093
|
|
|
Primary Sponsor
|
| Name |
Marico Ltd. |
| Address |
Plot No: 23/C, Mahal Industrial Estate, Near Ahura Centre, Paper Box Gali, Mahakali Caves Road, Andheri (E), Mumbai-400093 |
| Type of Sponsor |
Other [FMCG (Fast Moving Consumer Goods)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kirti Kate |
Ayurved Seva Sangh’s Ayurved Mahavidyalaya |
Department of Balaroga, OPD No 12, Ground Floor, Ayurved Seva Sangh’s Ayurved Mahavidyalaya, Ganeshwadi, Panchvati, Nashik, Maharashtra – 422003
Nashik
MAHARASHTRA |
9960394413
kate.kirti@gmail.com |
| Dr Deepak S Khawale |
DY Patil College of Ayurved and Research Centre, Pimpri, Pune |
Department of Kaumarbhritya OPD. No 1, Ground Floor, Dr. DY Patil College of Ayurved and Research Centre, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA |
9923220055
drdeepak77@rediffmail.com |
| Dr Sandip K Birari |
KVTR Ayurved College and Hospital |
Department of Kriya Sharir, OPD No 6, Ground Floor, KVTR Ayurved College and Hospital, Boradi, Tal.Shirpur, Dist Dhule, 425428
Dhule
MAHARASHTRA |
9404582991
sandipbirari@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ayurved Seva Sangh Ayurved Mahavidyalaya, Nashik |
Approved |
| Institutional Ethics Committee, DY Patil College of Ayurved and Research Centre, Pimpri, Pune |
Submittted/Under Review |
| Institutional Ethics Committee, KVTR Ayurved College and Hospital, Boradi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Neonates |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: Ashtang Sangraha, Procedure details: Mother will be asked to employ the standard massage regimen for the entire study period of 3 months )
(1) Medicine Name: Nourishing Baby Massage oil , Reference: Ayurvedic Proprietary Medicine, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: bd, Duration: 3 Months | | 2 | Comparator Arm (Non Ayurveda) | | - | Marketed Preparation Oil | Massage with marketed preparation oil twice a day for 3 months |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Full term (born after 37 weeks of gestation) and preterm (born prematurely prior to 37 weeks gestation), either normal or C-Section, neonates (till the age of 28 days) weighing 2500 grams at the time of recruitment or more will be included if they fulfill the following inclusion criteria:
1. Apgar score >7 at 1 and 5 minutes with no resuscitation required at birth.
2. Medically stable with no requirement of drugs, or any interventions/procedures other than Nutraceuitcal / health supplement.
3. Parents of the babies willing to sign an informed consent
|
|
| ExclusionCriteria |
| Details |
1. Neonates not on breast feed
2. Sick babies and those babies who have congenital anomalies or neuromuscular disorders.
3. Babies with muscular trauma or skin infections.
4. Parents of the Babies not willing to come for follow-up when required
5. Babies participating in any other clinical trials.
6. Known hypersensitivity to any of the ingredients of study product
7. Other conditions, which in the opinion of the investigators, make subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in anthropometrical measurements from baseline to each follow visit and against control.
2. Changes in Z score from baseline to each follow visit and against control
|
Screening/ Baseline visit (Day 0), Visit 1 (Day 15), Visit 2 (Day 30), Visit 3 (Day 45), Visit 4 (Day 60), Visit 5 (Day 75), Visit 6 (Day 90) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in orientation state, effect on mood, activity status, cooperation for massage and fidgeting/nervous behavior of subjects prior to massage, during massage and post massage
2. Changes in sleep pattern
3. Changes in Softness / suppleness / smoothness of skin
4. Changes in muscle and bone strength
5. Time taken for major milestones
6. Changes in food intake on
7. Changes in episodes, severity and duration of illness (infections or allergies)
8. Changes in skin condition.
9. Overall change in growth and behavior by investigator and parents / legal guardian
10. Assessment of adverse events and vitals
11. Tolerability of oil massage as per the parents / legal guardian and investigator
|
Screening/ Baseline visit (Day 0), Visit 1 (Day 15), Visit 2 (Day 30), Visit 3 (Day 45), Visit 4 (Day 60), Visit 5 (Day 75), Visit 6 (Day 90) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/11/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet Done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an open labeled, randomized, multi-centric, comparative, prospective, clinical study to evaluate efficacy and safety of Nourishing Baby Massage oil in growth, development, muscle strength and behavioral assessment of Neonates. The study will be carried out at 3 to 4 centers in India. Parents/ legal guardian in group I will be asked to do massage of their neonate with Nourishing Baby Massage oil twice daily for 3 months and Parents/ legal guardian in group II will be asked to do massage of their neonate with marketed preparation oil twice a day for 3 months. The primary objectives of the study will be to assess changes in anthropometrical measurements and Z score from baseline to each follow visit and against control. The secondary objectives of the study will be to assess changes in orientation state, effect on mood, activity status, cooperation for massage and fidgeting/nervous behavior of subjects prior to massage, during massage and post massage, changes in sleep pattern, changes in Softness / suppleness / smoothness of skin, changes in muscle and bone strength, time taken for major milestones, changes in food intake, changes in episodes, severity and duration of illness (infections or allergies), changes in skin condition, overall change in growth and behavior by investigator and parents / legal guardian, adverse events and vitals and tolerability of oil massage as per the parents / legal guardian and investigator. |