| CTRI Number |
CTRI/2024/10/075291 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Kumarkalyana ghrita in underweight in children |
|
Scientific Title of Study
|
Evaluation of Kumarkalyana ghrita in management of underweight in children – a randomized controlled 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 |
Dr Laxman N Zargad |
| Designation |
PG Scholar |
| Affiliation |
KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka |
| Address |
Department of Kaumarabhritya KAHER Shri B M Kankanawadi
Ayurveda Mahavidyalaya Belagavi Karnataka
Belgaum
KARNATAKA
590003
India
Belgaum KARNATAKA 590003 India |
| Phone |
9011165828 |
| Fax |
|
| Email |
zargadlaxman1996@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Veena Tonne |
| Designation |
Associate Professor |
| Affiliation |
KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka |
| Address |
Department of Kaumarabhritya KAHER Shri B M Kankanawadi
Ayurveda Mahavidyalaya Belagavi Karnataka
Belgaum
KARNATAKA
590003
India
Belgaum KARNATAKA 590003 India |
| Phone |
09538469641 |
| Fax |
|
| Email |
dr.veenatonne@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Veena Tonne |
| Designation |
Associate Professor |
| Affiliation |
KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka |
| Address |
Department of Kaumarabhritya KAHER Shri B M Kankanawadi
Ayurveda Mahavidyalaya Belagavi Karnataka
Belgaum
KARNATAKA
590003
India
Belgaum KARNATAKA 590003 India |
| Phone |
09538469641 |
| Fax |
|
| Email |
dr.veenatonne@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Post Graduate Studies And Research
Centre Shahapur Belagavi Karnataka India 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Laxman N Zargad |
| Address |
KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Post
Graduate Studies And Research Centre Shahapur Belagavi
Karnataka India 590003 |
| Type of Sponsor |
Other [(Self)] |
|
|
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 VEENA TONNE |
Kl Ayurveda Hospital |
OPD no 10,
Department of
Kaumarbhritya KLE
Shri B.M.K Ayurveda
Mahavidyalaya,
Belagavi
Belgaum
KARNATAKA Belgaum KARNATAKA |
9538469641
dr.veenatonne@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research On Human Subjects KAHER Shri B M Kananwadi Ayurveda Mahavidyalaya  Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E639||Nutritional deficiency, unspecified. Ayurveda Condition: KARSYAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KUMARAKALYANA GHRITA, Reference: BHAISHJYA RATNAVALI , Route: Oral, Dosage Form: Ghrita, Dose: 4.5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: LIKE WARM MILK), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha ghrita , Reference: BHAISHYJA RATNAVALI BALROG ADHIRKAR 71/132, Route: Oral, Dosage Form: Ghrita, Dose: 4.5(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -LUKE WARM MILK), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children fulfilling diagnostic criteria
Children with normal appetite measured by score 7- 8 on hunger rate scale
|
|
| ExclusionCriteria |
| Details |
Children with weight for age more than median.
Children with known cases of tuberculosis, liver disorders, neurological & endocrine disorders.
Children who are currently using other medications like steroids etc will be excluded.
Children on any form of food supplements.
Children known with lactose intolerance.
Children with any development disability like Cerebral palsy , Mental retardation etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
There might be a significant effect of Kumarkalyana ghrita in management of underweight in children.
PRIMARY OUTCOME: Measured by changes in weight and BMI.
|
0TH DAYS
15TH DAYS
30TH DAYS
45TH DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Weight
BMI
Skin fold thickness
Height
Chest circumference
Mid Arm circumference
Assessment as per classical lakshanas of krishata
|
0TH DAYS
15TH DAYS
30TH DAYS
45TH DAYS |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="2" Months="0" 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
|
Malnutrition
is the major global health problem in children which affects large numbers of
children in developing countries. Under nutrition or underweight children are
those who have their expected weight for age to be between (-2)SD to (-3) SD in
growth chart.(1) Nearly half of
deaths among children under 5 years of age are linked to undernutrition. These
mostly occur in low- and middle-income countries. The developmental, economic,
social and medical impacts of the global burden of malnutrition are serious and
lasting, for individuals and their families, for communities
and for countries(2). As per NFHS 5 in India shows 32.1%
were underweight, 35.5% were stunted
& 19.3% were wasted.(3)Good nutrition leads to stronger immune
system, low illness, better health whereas chronic malnutrition hampers
immunity & makes the child susceptible to various
infections.Malnutrition can cause
missing key nutrients, which can affect brain development and slower growth. Despite
numerous interventions and initiatives aimed at minimizing malnutrition and
mortality among children, the situation remains a major concern that requires
some more action. At present, the line of treatment adopted is administering
nutritional supplements, anti-helminthic drugs, etc The protein powders are the
most commonly used health supplement. Its components like fibre and isolates of
soya protein may lead to gastro-intestinal problems like constipation,
bloating, and nausea.(4) In Ayurveda various drugs have been
mentioned which have pustikar, balya, brihmana karma and can have
multidimensional effect on improving child’s nutrition and health. Kumarkalyana
Ghrita is one of the drug mentioned
in classics which posses karmas like pustikar and balya.(5)
Therefore, this study is taken for the management of underweight in
children. |