| CTRI Number |
CTRI/2025/03/083570 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on Low Birth Weight neonates for improving weight gain and sleep quality |
|
Scientific Title of Study
|
Efficacy of Bala ashwagandhadi Taila Abhyanga (Massage) on improving weight gain and sleep quality in Low-Birth-Weight neonates (Alpabhara Shishu)- an open-labelled Randomized Comparative Clinical 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 |
Kanika Bhatia |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Kaumarabhritya, 4th floor academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road, New Delhi
South
DELHI
South
DELHI
110076
India |
| Phone |
8894167017 |
| Fax |
|
| Email |
kanikabhatia19944@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahapatra Arun Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Kaumarabhritya, 4th floor academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road, New Delhi
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
8506821947 |
| Fax |
|
| Email |
ayuarun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajagopala S |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Ayurveda, New Delhi |
| Address |
Department of Kaumarabhritya, 4th floor academic
block, All India Institute of Ayurveda, Gautampuri
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
7600902564 |
| Fax |
|
| Email |
srajagopala@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Mathura Road, Gautampuri, Sarita Vihar, New Delhi, India, Pin code-110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda, New Delhi |
| Address |
All India Institute of Ayurveda, Gautampuri,Sarita Vihar, Mathura Road, New Delhi-110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kanika Bhatia |
All India Institute of Ayurveda, New Delhi |
OPD 208, Department of Kaumarabhritya, 2nd floor, hospital Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road, New Delhi
South
DELHI |
8894167017
kanikabhatia19944@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Ayurveda New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:P071||Other low birth weight newborn. Ayurveda Condition: KARSYAM (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Ashtang Hridyam Uttar Tantra 1, Procedure details: Abhyanga will be done one hour before the feed to avoid regurgitation of milk Abhyanga will be done for 15 minutes by mothers twice per day
Massage oil will be preheated slightly indirectly to make it lukewarm Mothers will apply oil to their palms the quantity of oil used in each session will depend on the surface area of the newborn Oil Massage will be performed with fingers for the entire body and with palms for the newborn joints back abdomen palms and soles Massage will be performed with minimal pressure by applying just enough force to diffuse the oil into the skin and feel comforting to the neonate Massage will be performed in this sequence chest abdomen shoulders upper limbs lower limbs head and face neck back and buttocks Bathing will be advised after one hour of massage session
)
(1) Medicine Name: Balashwagandahi Taila, Reference: Sahasrayogam Taila Prakarna, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: bd, Duration: 42 Days | | 2 | Comparator Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Ashtang Hridyam Uttar tantra 1, Procedure details: Abhyanga will be done one hour before the feed to avoid regurgitation of milk Abhyanga will be done for 15 minutes by mothers twice per day
Massage oil will be preheated slightly indirectly to make it lukewarm Mothers will apply oil to their palms the quantity of oil used in each session will depend on the surface area of the newborn Coconut oil Massage will be performed with fingers for the entire body and with palms for the newborn joints back abdomen palms and soles Massage will be performed with minimal pressure by applying just enough force to diffuse the oil into the skin and feel comforting to the neonate Massage will be performed in this sequence chest abdomen shoulders upper limbs lower limbs head and face neck back and buttocks Bathing will be advised after one hour of massage session
)
(1) Medicine Name: Narikela Taila, Reference: Arogya Rakshakalpadrum 1, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: bd, Duration: 42 Days |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1. Clinically stable Low Birth Weight neonates (1.5 kg to 2.499 kg) irrespective of sex and ethnicity.
2. Born via NVD and LSCS with an APGAR score of more than 7 in the first minute of birth.
3. Neonates with a history of LBW, up to 6 months of age (if weight is not appropriate to age at the time of assessment) visiting the hospital for routine checkups and vaccination.
4. Gestational age at birth should be above 28 weeks
|
|
| ExclusionCriteria |
| Details |
1. Very Low Birth Weight Neonates
2. Extremely pre-term neonate
3. Skin Diseases (Atopic Dermatitis, napkin Rash, contact dermatitis, etc.)
4. Birth Injuries
5. Pathological Neonatal Jaundice
6. Major congenital anomaly, newborn in NICU,
7. Congenital Infections, CNS Dysfunction e.g. Intraventricular Haemorrhage and History of Seizures
8. TPN, Mechanical Ventilation, and supplementary oxygen therapy
9. Neonates developing fever, signs of sepsis, respiratory distress, necrotizing enterocolitis, seizures, neurological dysfunction, or any other illnesses.
10. Neonates sensitive to massage oil test dose
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To achieve age-appropriate improvement in weight gain (velocity) in LBW neonates. |
At Birth or at time of enrollment, Day 21 and Day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Age-appropriate increase in length, head circumference, and skinfold thickness.
Improvement in quality of sleep
Changes in the score of the NBAS Scale |
Day1, Day21, Day 42
NBAS Day1 and Day 42 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Introduction Low Birth weight infants born premature or small for gestational age constitute about 15 percent of neonates but account for 70 percent of all neonatal deaths infants born with low birth weight are at risk of linear growth faltering cognitive and motor deficits as well as lower academic performance and behavioural problems compared to normal birth weight infants Low Birth Weight harms child survival causing 40 to 80 percent of neonatal deaths owing to related complications stunted growth disabilities deficits in neurological development Ayurveda classical Acharya Charaka in Sharir Sthana has mentioned leena Garbha upvishtaka nagodar and Garbha shosha which can be compared with IUGR babies due to maternal causes which ultimately leads to Low Birth Weight babiesThis is a comparative clinical trial where an herbal oil Balaashwagandhadi taila abhyanga massage will be compared with a traditionally used Coconut oil Narikela taila abhyanga Coconut oil massage has been proven to have positive results in weight gain velocity and length gain velocity in neonates Methodology Participants 50 per group Sample size 100 Study design Randomized comparative clinical trial Intervention Group A Abhyanga with Balashwagandhadi Taila twice per day for 15 min by mothers Comparator Group B Abhyanga with Narikela Taila twice per day for 15 min by mothers Duration 6 weeks Follow Up 2 weeks Primary Objectives To evaluate and compare the efficacy of Balaashwagandhaadi Taila Abhyanga oil massage and traditionally used Narikela Taila Abhyanga oil massage done according to the Ayurveda neonatal massage protocol for 15 minutes twice per day for 6 weeks on weight gain among LBW neonates Secondary Objectives To evaluate and compare the efficacy of Balaashwagandhadi Taila Abhyanga and Narikela Taila Abhyanga on length head circumference and skinfold thickness among LBW neonates To determine and compare the effect of Balashwagandhadi Taila Abhyanga and Narikela Taila abhyanga on quality of sleep among LBW neonates To analyse and compare the effect of Balaashwagandhadi Taila Abhyanga and Narikela Taila Abhyanga on the Neonatal Behavioural Assessment Scale among LBW neonates Inclusion Criteria Clinically stable Low Birth Weight neonates 1500 grams to 2499 grams irrespective of sex and ethnicity Born via NVD and LSCS with an APGAR score of more than 7 in the first minute of birth Neonates with a history of LBW up to 6 months of age if weight is not appropriate to age at the time of assessment visiting the hospital for routine checkups and vaccination Gestational age at birth should be above 28 weeks Exclusion Criteria Very Low Birth Weight Neonates Extremely preterm neonate Skin Diseases Atopic Dermatitis napkin Rash contact dermatitis etc Birth Injuries Pathological Neonatal Jaundice Major congenital anomaly newborn in NICU Congenital Infections CNS Dysfunction for example Intraventricular Haemorrhage and History of Seizures TPN Mechanical Ventilation and supplementary oxygen therapy Neonates developing fever signs of sepsis respiratory distress necrotizing enterocolitis seizures neurological dysfunction or any other illnesses Neonates sensitive to massage oil test dose Criteria for Diagnosis Low Birth weight 1500 grams to 2499 grams Falling Below the tenth percentile on the growth chart or Small for gestation Age Neonates Stable Preterm and IUGR Neonates Withdrawal Criteria Parents demanding withdrawal from the study Noncompliance with study protocol Mothers on narcotic agents barbiturates aspirin chloral hydrate reserpine and phenytoin sodium as medications Outcomes Primary Outcome To achieve age appropriate improvement in weight gain velocity in Low birth weight neonates Secondary Outcome Age appropriate increase in length head circumference and skinfold thickness Improvement in quality of sleep Changes in the score of the Neonatal Behavioural Assessment Scale |