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CTRI Number  CTRI/2024/07/070272 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 01/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An Interventional study to evaluate the effect of Ashwagandhadi leha in participients of malnutrition 
Scientific Title of Study   Development and validation of a tool to assess Agni bala and role of Ashwagandhadi leha with Agni deepana in the management of malnutrition in children  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Nisha Kumari Ojha 
Designation  Professor and H.O.D. 
Affiliation  National Institute of Ayurveda, JAIPUR 
Address  Department of Kaumarbhritya, Room no. 222, National Institute of Ayurveda, Deemed to be University,Amer road, Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9468650449  
Fax    
Email  drnishaojha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Nisha Kumari Ojha 
Designation  Professor and H.O.D. 
Affiliation  National Institute of Ayurveda, JAIPUR 
Address  Department of Kaumarbhritya, Room no. 222, National Institute of Ayurveda, Deemed to be University, Amer road, Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9468650449  
Fax    
Email  drnishaojha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anand Khatri 
Designation  PG Scholar 
Affiliation  National institute of ayurveda, jaipur 
Address  Department of Kaumarbhritya, Room no. 222, National Institute of Ayurveda, Deemed to be University, Amer road, Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8209345583  
Fax    
Email  anandkhatri786@gmail.com  
 
Source of Monetary or Material Support  
Vice Chancellor, National Institute of Ayurveda, Deemed to be University, Amer road, Jorawar singh gate, Jaipur 
 
Primary Sponsor  
Name  no sponsor 
Address  nil 
Type of Sponsor  Other [nil] 
 
Details of Secondary Sponsor  
Name  Address 
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 
Dr Anand Khatri  National Institute of Ayurveda, jaipur  OPD no. 5, National Institute of Ayurveda, Jorawar singh gate, Amer road
Jaipur
RAJASTHAN 
8209345583

anandkhatri786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, National Institute of Ayurveda, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E441||Mild protein-calorie malnutrition. Ayurveda Condition: KARSYAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Ashwagandhadi leha, Reference: Sahastra yoga, Avaleha prakarana, chapter 13, Shloka no. 1,page no. 343, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Milk), Additional Information:
2Intervention ArmDrugClassical(1) Medicine Name: Trikatu churna , Reference: Bhaishajya Ratnavali ,Paribhasha prakarana, shloka no.16, Route: Oral, Dosage Form: Churna/ Powder, Dose: 0.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -luke warm water ), Additional Information: -
(2) Medicine Name: Ashwagandhadi leha , Reference: Sahasra yoga, Avaleha prakarana, chapter 13, Shloka no. 1,page no. 343,, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -Milk), Additional Information: -
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Children between 2 to 12 years of age of either sex.
2. Children with mild to moderate grade of malnutrition
3. Children whose parents are willing to give consent for clinical trial.
 
 
ExclusionCriteria 
Details  1) Children suffering from known major systemic illness necessitating hospitalization.
2) Children with evidence of malignancy, genetic or congenital anomaly.
3) Children with known Mal-absorption syndrome or inborn errors of Metabolism.
4) Children with severe acute malnutrition.
5) H/O Hypersensitivity to any of the trial drug or their ingredients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Weight  at time of enrollment, 4 weeks, 8 weeks, 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
• Change in symptoms of malnutrition
1. Jwara (fever )
2. Pratishyaya ( cold )
3. Arochaka ( lack of appetite )
4. Kasa ( cough)

• Change in Anthropometric measurement
• Weight in kg
• Height in cm
• Mid arm circumference ( Evaluate upto 5 year of age)
• Skin fold thickness( biceps and triceps)

 
12 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/08/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Departmental Library, Department of Kaumarbhritya, National Institute of Ayurveda, Amer road, Jaipur

  6. For how long will this data be available start date provided 01-08-2024 and end date provided 01-08-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Compared to other stages, childhood is the stage when growth and development occurs. A healthy diet or good nutrition is the main factor in children’s growth and development. In developing nations like India, where there is still widespread poverty, illiteracy, and social ignorance, childhood malnutrition remains a serious public health concern. Child malnutrition is a pathological condition that results from poor nutrition, according to one definition. Carbohydrates, proteins, fats, vitamins, and minerals must all be a part of a growing child’s diet.

Malnutrition refers to both undernutrition and over nutrition and where undernutrition is characterized by low weight-for-age (underweight), length-for-age (stunting), or weight-for-length (wasting) and micronutrients deficiency.

Wasting is defined as low weight-for-length. It often indicates recent and severe weight loss, although it can also persist for a long time. It usually occurs when a person has not had food of adequate quality and quantity and/or they have had frequent or prolonged illnesses. Wasting in children is associated with a higher risk of death if not treated properly. Stunting is defined as low height-for-age. It is the result of chronic or recurrent undernutrition, usually associated with poverty, poor maternal health and nutrition, frequent illness and/or inappropriate feeding and care in early life. Stunting prevents children from reaching their physical and cognitive potential. Underweight is defined as low weight-for-age. A child who is underweight may be stunted, wasted or both.

Micronutrient deficiencies are a lack of vitamins and minerals that are essential for body functions such as producing enzymes, hormones and other substances needed for growth and development.

Progressive reducing appetite, encouraging catabolism, and increasing demand for nutrients, and repeated cases of morbidity exacerbate malnutrition. In addition, malnourished children are more vulnerable to systemic infections. The World Health Organization (WHO) estimates that incorrect dietary intake accounts for one-third of all cases of child malnutrition. The primary cause of death among children, according to UNICEF’s State of the World’s Children 2019 report, was malnutrition. Early-life chronic malnutrition stunts growth and development, retards brain development, and saps a child’s willpower and vitality.

Ailment called "Balashosha" by Acharya Vagbhatta is similar to malnutrition. Ayurveda lists three particular etiological factors: sleeping too much during the day, drinking too much cold water, and ingesting breast milk with a vitiated Kapha. The aetiology of this illness results from an abnormal accumulation of Kapha, which blocks the Rasavaha Srotas, hinders the nourishing of subsequent Dhatu like Rakta Mamsa and Meda, etc., and reduces children’s growth and development due to general Dhaatu kshaya. Arochaka (reduced digestive capacity), Pratishayaya (running nose), Jwara (fever), and Kasa (cough) are symptoms of recurring illness which are caused by immune system being severely damaged by calorie and protein shortage. Balashosha (emaciation) is brought on by such recurrent infections along with additional precipitating variables. Since Balshosha is a part of Aptarpanajanya Vyadhies, Santarpana Chikitsa must be involved in its management. Two things are implied by Santarpana Chikitsa: management of Agni and the feeding of Dhatu

 
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