| CTRI Number |
CTRI/2022/10/046518 [Registered on: 14/10/2022] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical evaluation for safety and efficacy of Lactohil Plus (Banana Flavour) in the management
of inadequacy of lactation (Stanyakshaya) |
|
Scientific Title of Study
|
A single center randomized single blind comparative clinical trial to evaluate the safety and
efficacy of Lactohil Plus (Banana Flavour) in the subjects suffering with inadequacy of lactation
(Stanyakshaya).
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHARATHI KUMARAMANGALAM |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda
Deemed to be university
Jorawar Singh Gate
Amer Road Jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9492047131 |
| Fax |
|
| Email |
baruhunt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BHARATHI KUMARAMANGALAM |
| Designation |
PROFESSOR AND HAED |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda
Deemed to be university
Jorawar Singh Gate
Amer Road Jaipur 302002
National Institute of Ayurveda
Deemed to be university
Jorawar Singh Gate
Amer Road Jaipur 302002
RAJASTHAN
302002
India |
| Phone |
9492047131 |
| Fax |
|
| Email |
baruhunt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BHARATHI KUMARAMANGALAM |
| Designation |
PROFESSOR AND HAED |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda
Deemed to be university
Jorawar Singh Gate
Amer Road Jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9492047131 |
| Fax |
|
| Email |
baruhunt@gmail.com |
|
|
Source of Monetary or Material Support
|
| HLL Lifecare Limited
(A Government of India Enterprise)
HLL Bhavan, #26/4, Tambaram-Velachery Main Road, Pallikarnai, Chennai-600100 |
|
|
Primary Sponsor
|
| Name |
HLL Lifecare Limited |
| Address |
HLL Bhavan, #26/4,
Tambaram-Velachery Main Road,
Pallikaranai |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Nil |
Nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bharathi Kumaramangalam |
National Institute of Ayurveda Hospital |
OPD No 26 and 27
Arogyashala
National Institute of Ayurveda
Jorawar Singh gate
Amer Road
Jaipur 302002
Jaipur
RAJASTHAN |
9492047131
baruhunt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O925||Suppressed lactation. Ayurveda Condition: STANYAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Lactohil Plus, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Milk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatavari , Reference: Pharmacopoeia I., Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Female |
| Details |
Lactating mothers age between 21 to 35 years
Lactating mothers who delivered at term without complication
Baby weight not less than 2000 g at birth
Baby between 10-180 days of age
Failure to regain infant’s birth weight at 15 days of life
Mothers supplementing top feed ≥250 ml/day after 4 weeks of birth |
|
| ExclusionCriteria |
| Details |
Mothers
Chronic diseases such as Tuberculosis, malignancy and AIDS
Breast abscess, cracked nipples, epilepsy, psychosis, alcohol addiction, and mastitis
Had previous breast surgery
Infants
Weight less than 2000g
Prematurity and inborn errors |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total elimination or significant reduction in volume of supplementary feed and weight gain of the baby |
on baseline, 15th day, 30th day, 45th day, 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
improvement in
subjective satisfaction of mothers regarding the well being and happiness of babies, feeling
fullness in the breast during breast feeding, contra lateral ejection of the milk, and mother’s
observation regarding increase in milk. |
at baseline, 15th day, 30th day, 45th day, 60th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/10/2022 |
| Date of Study Completion (India) |
09/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Breast milk is the ideal food for newborns and infants. Exclusive breastfeeding is recommended up to 6 months of age, with continued breastfeeding along with appropriate complementary foods up to two years of age or beyond. If breastfeeding were scaled up to near universal levels, about 820 000 child lives would be saved every year . Globally, only 40% of infants under six months of age are exclusively breastfed. WHO actively promotes breastfeeding as the best source of nourishment for infants and young children? This fact file explores the many benefits of the practice, and how strong support to mothers can increase breastfeeding worldwide . Every infant and child has the right to good nutrition according to the "Convention on the Rights of the Child". Undernutrition is associated with 45% of child deaths. Globally in 2016, 155 million children under 5 were estimated to be stunted (too short for age), 52 million were estimated to be wasted (too thin for height), and 41 million were overweight or obese . It has been estimated that 23 to 63 % incidence of inadequacy of lactation is found during the first 4 months after delivery . Hence, galactagogues are used to increase milk production. Although certain medicines like metoclopramide and domperidone are being used for augmenting lactation but are seldom recommended in view of their limited efficacy prospects and major safety concern. graded scale ranging from 1 to 5 (1 denoting unsatisfactory and 5 representing highly satisfactory) Thus, there has been no effective western medical treatment for the illness so far. However, from earliest times of mankind a multitude of plant galactagogues has been used in the folk medicine of all human cultures. Some herbs i.e. Shatavari (Asparagous racemosus), Kash (saccharaum spontaneum), Ikshu (Saccharum officinarum), Usheera (Viveria zizanoides) and Gundra (Typha elephantia) etc. These are said as having Stanyajana properties. After a complete systemic review, some most effective which are available in market, modern studies also prove their safety and efficacy, cheaper in cost, having higher nutrition values are selected and a new formulation was developed and named as Lactohil Plus. So here in the present study clinical study of Lactohil Plus has been planned. AIM: The aim of the study is to evaluate the efficacy of Lactohil Plus in the management of inadequacy of lactation (Stanyakshaya). OBJECTIVES:  To evaluate the effect of the formulation on subjective and objective parameters (end points).To observe and analyze any adverse event occurs during trial duration and follow up to evaluate the safety of the trail drug.  Null Hypothesis: Lactohil Plus has no curative effect in the subject suffering from inadequacy of lactation(Stanyakshaya).  Alternative hypothesis: Lactohil Plus has significant curative effect on the subjects suffering from inadequacy of lactation (Stanyakshaya) and it is better or comparative to shatavari.  Research Question: Does Lactohil Plus has curative effect in the management of inadequacy of lactation (Stanyakshaya)? The reference(s)of the Drug(s) as given in Ayurvedic texts are cited,(photocopies of original references are attached) My project involves drug intervention in human subjects CRITERIA OF ASSESSMENT: The efficacy of test drug will be assessed by observing the increase in milk production. At baseline and after treatment the mothers will asked about following criteria:  Clinical Features of Lacto-genesis  Elimination or significant reduction in supplementary feeds  Baby weight gain The efficacy will be assessed by considering successful lactation in if the following subjective and objective criteria were fulfilled.  Subjective Parameters  Tingling sensation or feeling of fullness in the breast before and while breast feeding  Contra lateral ejection of milk flow during feeding  Satisfaction of baby after breastfeeding  Satisfaction of mother and observation regarding increase in breast milk  Objective Parameters  Total elimination or significant decrease in quantity of artificial milk or supplementary feed to the child per day  Baby weight gain INVESTIGATIONS: 1. LFT, RFT, Glucose Profile |