| 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
|
|
|
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
|
|
|
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 | Comparator Arm | Drug | Classical | | (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: | | 2 | Intervention Arm | Drug | Classical | | (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: - |
|
|
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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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Departmental Library, Department of Kaumarbhritya, National Institute of Ayurveda, Amer road, Jaipur
- 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.
- 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 |