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CTRI Number  CTRI/2025/03/082633 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical study on Herbal Gummy Formulation for Health Immunity and Cognition 
Scientific Title of Study   Evaluation of Safety and Efficacy of a Herbal Gummy Formulation in Health, Immunity and Cognition Related Parameters 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  Dr Lokeshwari H S 
Designation  Professor 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research Center 
Address  Department of Kaumarabhritya, Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research Center, Hampi Nagara, Vijaya Nagara

Bangalore
KARNATAKA
560104
India 
Phone  9740863441  
Fax    
Email  sundri1610@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lokeshwari H S 
Designation  Professor 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research Center 
Address  Department of Kaumarabhritya, Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research Center, Hampi Nagara, Vijaya Nagara

Bangalore
KARNATAKA
560104
India 
Phone  9740863441  
Fax    
Email  sundri1610@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Lokeshwari H S 
Designation  Professor 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research Center 
Address  Department of Kaumarabhritya, Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research Center, Hampi Nagara, Vijaya Nagara

Bangalore
KARNATAKA
560104
India 
Phone  9740863441  
Fax    
Email  sundri1610@yahoo.com  
 
Source of Monetary or Material Support  
Dabur Research and Development Centre, Plot No 22, Site IV, Sahibabad, Ghaziabad, UP, India 201010 
 
Primary Sponsor  
Name  DABUR INDIA LTD 
Address  Dabur Research and Development Centre, Plot no 22,Site IV Sahibabad, Ghaziabad, Uttar Pradesh 201010 
Type of Sponsor  Other [Ayurvedic Healthcare ] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lokeshwari HS  Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research center  Room No 19, Dept Kaumarabhrutya, 10 Pipeline Road, Hampinagara, Viajayanagara, bengalore
Bangalore
KARNATAKA 		 9740863441

sundri1610@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SKAMCHRC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Male and female children between 5-12 years of age  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Ksheera, Reference: A H 5, Route: Oral, Dosage Form: Ksheerpaka, Dose: 200(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugOther than Classical(1) Medicine Name: Herbal gummy, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: Nil
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Healthy Male & female children between 5-12 years of age (both inclusive).
2. Medically stable with no requirement of drugs, or any interventions/procedures or any nutraceutical / health supplement.
3. Children who are willing to drink milk regularly.
4. Parents/ Legally Acceptable Representative of children willing to provide an informed consent.
5. No significant medical or surgical disease/s at the time of screening
6. No history of allergic response to Chyawanprash like products/any ingredients of the Chyawanprash and are not averse to taste of Chyawanprash
7. Willing to come for the follow up visits for evaluation
 
 
ExclusionCriteria 
Details  1. Children with any underlying physical, psychological or surgical condition.
2. Children who are reluctant to drink milk regularly.
3. Children who required use of concomitant medications
4. Children who are currently taking any health supplement/nutraceuticals.
5. Known hypersensitivity to study drug or ingredients in the study drug.
6. Subjects participating in other clinical trials 3 months before recruitment.
7. Parents and teachers of the children not willing to sign Informed Consent
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in Immunity, cognitive health and quality of life   90 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Safety assessment basis incidence of adverse events, serious adverse events, and vitals during the study period.
2. Overall safety and tolerability of product by the physician and participant/parent will be evaluated at the end of the study.
 		 90 days 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   20/07/2025 
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="2"
Days="3" 
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 - NO
Brief Summary  

This study will be a single centred, open label; two arm randomized, parallel group clinical study to evaluate the safety and efficacy of a polyherbal gummies formulation DRDC/2024/0 in health, immunity, and cognition related parameters in children. One hundred and sixty (120 subjects) will be enrolled in the study, 60 will receive the study product followed by a glass (approx. 200 ml) and 60 will take a glass of milk only two times a day.

 

Healthy males and female school going children not more than 12 years of age, fulfilling the inclusion & exclusion criteria will be enrolled. Screening/baseline procedures will include medical history, physical examination, and vital signs. Assessment of clinical signs and symptoms, vitals and adverse Events will be done at every follow up visit on 4 weeks, 8 weeks, 12. Response to treatment will be measured by Anthropometry Scale, Wechsler Intelligence Scale for Children IV, Monthly record of school attendance, School performance and subjective parameters such as taste evaluation, Physician’s and Parents’ global evaluation in both the treatment arms.

 
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