FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091551 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 09/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The effectiveness of the Ayurvedic medication Bhringarajasava in treating malnutrition (balshosh ) in children aged three to six year 
Scientific Title of Study   EFFICACY OF BHRINGARAJASAVA IN THE MANAGEMENT OF BALSHOSHA IN PRE SCHOOL-CHILDREN: A RANDOMIZED CONTROLLED 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 Kamalesh Fagore 
Designation  Pg Scholar (kaumarbhritya dept) 
Affiliation  National Institute of Ayurveda Jaipur 
Address  opd no 5 department of kauarbhritya National Institute of Ayurveda hospital jorawar singh gate jaipur
opd no 5 department of kauarbhritya National Institute of Ayurveda hospital jorawar singh gate jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  9074535570  
Fax    
Email  kamleshfagore07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Nisha Ojha 
Designation  Head of Department and Professor(kaumarbhritya dept)  
Affiliation  National Institute of Ayurveda Jaipur 
Address  opd no 5 department of kauarbhritya National Institute of Ayurveda hospital jorawar singh gate jaipur
opd no 5 department of kauarbhritya National Institute of Ayurveda hospital jorawar singh gate jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  9074535570  
Fax    
Email  drnishaojha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Nisha Ojha 
Designation  Head of Department and Professor(kaumarbhritya dept)  
Affiliation  National Institute of Ayurveda Jaipur 
Address  opd no 5 department of kauarbhritya National Institute of Ayurveda hospital jorawar singh gate jaipur
opd no 5 department of kauarbhritya National Institute of Ayurveda hospital jorawar singh gate jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  9468650449  
Fax    
Email  drnishaojha@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jaipur 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Jorawar singh gate Amer road Jaipur 302002 
Type of Sponsor  Government medical college 
 
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 Kamalesh Fagore  National Institute of Ayurveda Jaipur  department of kauarbhritya, opd no 5
Jaipur
RAJASTHAN 		 9074535570

kamleshfagore07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   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: BALAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: bhringarajasav, Reference: sahastrayoga, Route: Oral, Dosage Form: Asava, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: jal), Additional Information: also follow ICMR National Institute of Nutrition Dietary guidline for indians 2024
2Comparator Arm (Non Ayurveda)-ICMR National Institute of Nutrition Dietary guidline for indians 2024
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Weight for height Z score of minus 1SD TO less than minus3SD
Children aged 3 year to 6 years of either sex with no major medical complication.
Mother and care taker trainable to provide home based diet.
Parents willing to participate in the clinical trial.
 
 
ExclusionCriteria 
Details  children suffering from severe malnutrition who need hospitilization.
Weight for height Z score is greater than minus 3SD .
Tuberculosis, Cerebral palsy, Congenital heart diseases, Known metabolic disorders, Known mal-absorption syndromes, Chromosomal malformations, Renal or hepatic disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Weight  every followup visit in every 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Ayurvedic symptoms of Balshosh
Change in MUAC, Skin fold thickness and BMI.
Change in Height in cm
Change in Chest circumference in cm 		 every followup visit in every 14 days 
 
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 2 
Date of First Enrollment (India)   25/09/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 - Proposals should be directed to [kamleshfagore07@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

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

NEED OF THE STUDY

                 Childhood under nutrition accounts for 45% of Under 5 mortality alone and poses a key public health challenge in India. It is a major global health problem, resulting in childhood morbidity, mortality, impaired intellectual development, suboptimal adult work capacity, and increased risk of diseases in adulthood.[i] As per recent report of NFHS 5 (2020-21)  the nutrition reveals that in Rajasthan 27.6% of children under the age of five are underweight, 31.8% are stunted and 16.8% are wasted.[ii]

                 Although India has shown remarkable progress and has a number of nutritional programs but still malnutrition is a big problem in our country. Several cultural, societal, and economic issues make it difficult to achieve the goals even with a variety of dietary programs. Considering all the variables, it is imperative that we stress the need of treating childhood malnutrition both preventatively and therapeutically.

                    India celebrates the first week of September as National Nutrition Week and dedicates the entire month for Nutrition related campaigns and activities. The Government of India had launched multiple schemes to address the problems of the high rate of malnutrition in India. But, still there is no satisfactory solution and management for malnutrition and it is the need of the time to look into the alternative systems for the management. Therefore with these perspectives the present trial entitled “A Clinical Study to Evaluate the Efficacy of Bhringarajasava in the Management of   Balshosha in pre school Children ” has been planned from Sahasra Yogam, Aasava Prakarana, page no.250-251.

Trial Drug: Bhringarajasava (Sahastra Yog, AsavaPrakran, second edition P.N.250-251)

S.N.

Name of Drug

Latin Name

Family

Useful Part

 

1.      

Bhringaraj

Ecliptaprostrata

Asteraceae

Whole plant

12.250lts

2.      

Haritaki

Terminalia chebula

Combretaceae

Fruit

384 gms

3.      

Pippali

Piper longum

Piperaceae

Fruit

96 gm

4.      

Jatiphala

Myristica fragrans

Myristicaceae

Fruit

96 gm

5.      

 Lavang

Syzygium aromaticum

 Myrtaceae

Flower Bud

96 gm

6.      

Twak

Cinnamomum zeylanicum

Lauraceae

Dry Bark

96 gm

7.      

Ela

Elettaria cardamomum

Zingiberaceae

Sd.

96 gm

8.      

Patri

Cinnamomum tamala

Lauraceae

Dried Leaf

96 gm

9.      

Nagkeshar

Mesua ferrea

Calophyllaceae.

Flower[i]

96 gm

10.   

Gudd

Jaggery

-----

9.600 kg

 


[i]Dravyaguna-Vijnan Vol. II by Prof. P.V. Sharma published by Chaukhambha Bharati Academy, Varanasi, India, Reprint 2009,                                                                                                                                          


[i] Black R et al. Maternal and child undernutrition and overweight in low-income and middleincome countries. Lancet, 2013;382:427–51

[ii]https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://main.mohfw.gov.in/sites/default/files/NFHS-5_Phase-II_0.pdf&ved=2ahUKEwis0qGRy92FAxWgdPUHHXV_BPMQFnoECDAQAQ&usg=AOvVaw1xbRlN9Fq5qBwWUSTTFg69

 
Close