| CTRI Number |
CTRI/2024/07/070599 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Nutritional] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic granules in Under nutrition school children |
|
Scientific Title of Study
|
Evaluation Of Balamoola Granules In Management Of Underweight In School Going Children -a randomised 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 |
DrPrakash Honnoli |
| Designation |
PG Sclolar |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya |
| Address |
Department of kaumarabhritya KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur,Belagavi-590003
Belgaum
KARNATAKA
590003
India |
| Phone |
7760891361 |
| Fax |
|
| Email |
prakashhonnoli333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena K H |
| Designation |
Associate Professor |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya |
| Address |
Department of kaumarabhritya KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur,Belagavi-590003
Belgaum
KARNATAKA
590003
India |
| Phone |
953846641 |
| Fax |
|
| Email |
dr.veenatonne@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena K H |
| Designation |
Associate Professor |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya |
| Address |
Department of kaumarabhritya KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur,Belagavi-590003
Belgaum
KARNATAKA
590003
India |
| Phone |
953846641 |
| Fax |
|
| Email |
dr.veenatonne@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi |
|
|
Primary Sponsor
|
| Name |
KLE Ayurveda Hospital |
| Address |
KAHER Shri BMK Ayurveda Mahavidyalaya ,Shahapur, Belagavi 590003 |
| 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 Veena K H |
KLE Ayurveda Hospital |
OPD NO 10, Department of Kaumarabhritya KLE Shri B.M.K Ayurved Mahavidhyalaya Shahapur Belagavi. Pin: 590003
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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E441||Mild protein-calorie malnutrition. Ayurveda Condition: KARSYAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Balamoola granules, Reference: Raj nighantu shatavhyadi varga, verse no- 94-95, Route: Oral, Dosage Form: Khanda /Granules, Dose: 4(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha granules, Reference: Bhavaprakash nighantu guduchyadi varga, verse no-189-190, Route: Oral, Dosage Form: Khanda /Granules, Dose: 4(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Malnutrition is the main global health problem of 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) to (-3) SD in growth chart.(1)
In 2021, different studies conducted in India on assessment of nutritional status of primary school children shows that the prevalence rate of underweight is between 18.33% to 50.05%. As per NFHS 5 in India shows 35.7% were underweight, 38.4% were stunted & 21% were wasted.(2) More than 200 million school age children are malnourished in India.
School going age is very significant because this is the main period of life to make the body store nutrients. Good nutrition leads to stronger immune system, low illness, better health whereas chronic malnutrition hampers immunity & makes the child susceptible to various infections.
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(3).
Therefore in Ayurveda various drugs have been mentioned with pustikara, balya, brhmana karma which can have multidimensional effect on child’s health.
Balamoola is one of the drug mentioned in classics which posses karmas like pustikara(4) , brmhana(5) and balya.
|
|
| ExclusionCriteria |
| Details |
Malnutrition is the main global health problem of 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) to (-3) SD in growth chart.(1)
In 2021, different studies conducted in India on assessment of nutritional status of primary school children shows that the prevalence rate of underweight is between 18.33% to 50.05%. As per NFHS 5 in India shows 35.7% were underweight, 38.4% were stunted & 21% were wasted.(2) More than 200 million school age children are malnourished in India.
School going age is very significant because this is the main period of life to make the body store nutrients. Good nutrition leads to stronger immune system, low illness, better health whereas chronic malnutrition hampers immunity & makes the child susceptible to various infections.
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(3).
Therefore in Ayurveda various drugs have been mentioned with pustikara, balya, brhmana karma which can have multidimensional effect on child’s health.
Balamoola is one of the drug mentioned in classics which posses karmas like pustikara(4) , brmhana(5) and balya.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
THERE MIGHT BE SIGNIFICANT EFFECT OF BALAMOOLA GRANULES IN UNDERWEIGHT CHILDREN
with assessment criteria-
height
weight
chest circumference
skin fold thickness
BMI
Clinical features of underweight |
0th day
23rd day
46th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in BMI |
45 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)
|
10/08/2024 |
| 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 main global health problem
of 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) to (-3) SD in growth chart.
In 2021, different studies conducted in India
on assessment of nutritional status of primary school children shows that the
prevalence rate of underweight is between 18.33% to 50.05%. As per NFHS 5 in
India shows 35.7% were underweight, 38.4% were stunted & 21% were wasted.More than 200 million school age children are malnourished in India.
School going age is very significant because
this is the main period of life to make the body store nutrients. Good
nutrition leads to stronger immune system, low illness, better health whereas
chronic malnutrition hampers immunity & makes the child susceptible to
various infections.
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.
Therefore in Ayurveda various drugs have been mentioned with pustikara,
balya, brhmana karma which can have multidimensional effect on child’s
health.
Balamoola is one of the drug mentioned
in classics which posses karmas like pustikara , brmhana and balya.
|