| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E440||Moderate protein-calorie malnutrition. Ayurveda Condition: KUMARASOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Other 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 | | 3 | Comparator Arm | Drug | Classical | | (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-ï¬ve 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. |