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CTRI Number  CTRI/2023/07/055188 [Registered on: 13/07/2023] Trial Registered Prospectively
Last Modified On: 13/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study on Moderate malnutrition in children aged 3-5 years 
Scientific Title of Study   Evaluation of the efficacy of Ayush-BR Leham in the management of Moderate malnutrition among children aged 3-5 years – A Multicenter Randomized Controlled Pilot study 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 Karthika A P 
Designation  Research Officer (Ayurveda) 
Affiliation  National Ayurveda Research Institute for Panchakarma 
Address  Technical section, Department of Ayurveda, Room No.18, 6th floor New Hospital building, National Ayurveda Research Institute for Panchakarma
Cheruturuthy
Thrissur
KERALA
679531
India 
Phone  9446502709  
Fax    
Email  drkarthikaap@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Karthika A P 
Designation  Research Officer (Ayurveda) 
Affiliation  National Ayurveda Research Institute for Panchakarma 
Address  Technical section, Department of Ayurveda, Room No.18, 6th floor New Hospital building, National Ayurveda Research Institute for Panchakarma
Cheruturuthy
Thrissur
KERALA
679531
India 
Phone  9446502709  
Fax    
Email  drkarthikaap@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Karthika A P 
Designation  Research Officer (Ayurveda) 
Affiliation  National Ayurveda Research Institute for Panchakarma 
Address  Technical section, Department of Ayurveda, Room No.18, 6th floor New Hospital building, National Ayurveda Research Institute for Panchakarma
Cheruturuthy
Thrissur
KERALA
679531
India 
Phone  9446502709  
Fax    
Email  drkarthikaap@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences, 61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Central Council for Research in Ayurvedic Sciences, Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan, No. 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi-110058  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kishor A Gavali  M.S Regional Ayurveda Research Institute, Jaipur  M.S Regional Ayurveda Research Institute, Indira Colony, Bani Park, Jhotwara Road, Jaipur-302016
Jaipur
RAJASTHAN 
7011908354

dr.kishorgavali@gmail.com 
Dr Karthika AP  National Ayurveda Research Institute for Panchakarma, Cheruturuthy  National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur, Kerala 679531
Thrissur
KERALA 
9446502709

drkarthikaap@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E440||Moderate protein-calorie malnutrition. Ayurveda Condition: KUMARASOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Aravindasava, Reference: API Part II, Volume II, Route: Oral, Dosage Form: Asava, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: -
2Intervention ArmDrugOther than Classical(1) Medicine Name: Ayush BR leham, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: Ayush BR leham will be administered subsequently after 4 weeks administration of Aravindasava. Advice will be given to follow Homely diet during the study period and follow up
3Comparator ArmDrugClassical(1) Medicine Name: Aravindasava, Reference: API Part II, Volume II, Route: Oral, Dosage Form: Asava, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: Advice will be given to follow Homely diet during the study and follow up period
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1. Children of age group between 3-5 years
2. Children with weight for age between -2 and -3 SD of the World Health Organization weight for age growth standards
3. Children without the presence of edema
4. Parents or caregivers willing to provide a written informed consent form for the participation of their children 
 
ExclusionCriteria 
Details  1. Children with diagnosed cases of serious health issues like heart diseases, lung diseases, concurrent hepatic disorder, renal disorder, congenital anomalies, inborn errors of metabolism, malignancy, tuberculosis, HIV etc that might interfere with nutritional recovery
2. Children with acute infections viz- respiratory tract infections, diarrhoea, fever etc
3. History of hypersensitivity to the trial drug or any of its ingredients
4. Patients who have completed participation in any other clinical trial during the past six months
5. Any other condition which the Investigator thinks may jeopardize the study  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of participants attaining a change in weight for age z score by 0.5 or more as per WHO reference standards  Time frame 16 weeks
assessment at baseline & 12th week followed by assessment at 16th week 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the anthropometric measurements (weight, height, BMI, mid upper arm circumference)  Time frame 16 weeks – assessment at baseline, every 2 weeks in the first 12 weeks followed by assessment at 16th week 
Change in the frequency of illnesses   Time frame 16 weeks – assessment at the baseline, 12th week & 16th week 
Safety parameters assessed on the basis of biochemical parameters   Time frame 12 weeks – assessment at the baseline, 12th week 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 
Date of First Enrollment (India)   03/08/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   After completion of the study, the results will be published in peer reviewed journals. No publications done yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Malnutrition from a worldwide perspective, is one of the leading causes of mortality and morbidity in childhood. Under weight among under five children ranges from 39%-75% in different parts of the country. Prevalence of undernutrition among under-five children according to NFHS 4 (2015-16) in India shows that 35.7% were underweight, 38.4% were stunted and 21% were wasted. Undernutrition kills or disables millions of children every year and prevents millions of children reaching their full potential. Under nutrition is associated with impaired immune function and consequent increased susceptibility to infections; infections aggravate undernutrition; if this vicious cycle continues it can even result in death of the child. Early detection of malnutrition is essential in under-five children, so that timely interventions can be planned and implemented at the community level. So, it is the need of the hour to tackle this problem for better growth and development of the child with good immunity.

Nutrition in early childhood plays an important role in bringing positive health outcomes in children. Nutritional status of children can be considered as a proxy indicator of community’s health status. Low per capita income, poor environment sanitation, diseases, infections, inadequate access to primary health care, inappropriate childcaring and feeding practices in majority of Indian families leads to undernutrition of children and also affects their physical and mental development. Although different intervention programs are implemented in India to tackle this problem, no significant reduction has been observed in the burden of under-nutrition in under-five children.

According to Ayurveda, malnutrition in children is explained under various terminologies viz: Kumarasosha, Phakka, Parigarbhika, Karshya etc. All these disease conditions have agnimandya (impaired digestion and metabolism) and srotorodha (obstruction in body channels) leading to dhatu sosha (undernourished tissues) as the underlying pathology. Here primary emphasis should be given to correction of agni (digestion and metabolism) and srotorodha by deepana, pachana drugs (drugs correcting digestion and metabolism) followed by improving the quality and quantity of dhathus by brimhana (nourishing) therapy. This will improve the nutritional status, bestow immunity and good health to the child thereby preventing further infections. Such a treatment protocol may provide a sustained effect in the growth of the child. The present study is intended to study the effect of Ayush-BR leham in children with moderate malnutrition aged 3-5 years. Prior to the administration of Ayush BR leham, Aravindasava which is having Deepana pachana properties is given in both groups. The ingredients in Ayush-BR leham is having brimhana and antimicrobial properties which may help in improving anthropometric parameters and immunity of the child.

 
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