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CTRI Number  CTRI/2024/10/074863 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 07/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   Effect of nalikera ksheera khanda as diet supplement to improve BMI and Mid Arm Circumference of underweight adolescents among the age group of 13 to 18 years  
Scientific Title of Study   Effect of Nalikera Ksheera Khanda in management of underweight among adolescents 
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.Anagha Sankar 
Designation  PG Scholar 
Affiliation  Government Ayurveda College Tripunithura 
Address  Department of swasthavritta Government Ayurveda College and Hospital, Dhanwantari Nagar, Tripunithura

Ernakulam
KERALA
682301
India 
Phone  09633998111  
Fax    
Email  dr.anaghasankar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Jayan D 
Designation  Professor and HOD 
Affiliation  Government. Ayurveda College Tripunithura 
Address  Department of swasthavritta Government Ayurveda College and Hospital, Puthiyakavu, Dhanwantari Nagar, Tripunithura

Ernakulam
KERALA
682301
India 
Phone  09633998111  
Fax    
Email  dr.jayan.d@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Anagha Sankar 
Designation  PG Scholar 
Affiliation  Government Ayurveda College Tripunithura 
Address  Department of swasthavritta Government Ayurveda College and Hospital, Puthiyakavu, Dhanwantari Nagar, Tripunithura

Ernakulam
KERALA
682301
India 
Phone  09633998111  
Fax    
Email  dr.anaghasankar@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College and Hospital, Puthiyakavu, Dhanwantari Nagar, Tripunithura, Ernakulam Kerala India 682301 
 
Primary Sponsor  
Name  Government Ayurveda College and Hospital Tripunithra 
Address  Department of Swasthavritta, Government Ayurveda College and Hospital, Puthiyakavu, Dhanwantari Nagar, Tripunithura 682301, Ernakulam , Kerala, India 
Type of Sponsor  Other [Government Ayurveda 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 
DrANAGHA SANKAR  Govt Ayurveda College and Hospital Tripunithura  DEPARTMENT OF SWASTHAVRITTA GOVERNMENT AYURVEDA MEDICAL COLLEGE, DHANVANTRI NAGAR, PUTHIYAKAVU, TRIPUNITHURA,ERNAKULAM
Ernakulam
KERALA 		 9633998111

dr.anaghasankar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH Govt. Ayurveda College Tripunithura Kochi Kerala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E648||Sequelae of other nutritional deficiencies. Ayurveda Condition: KARSYAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ashtachoorna, Reference: Ashtangahridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information: -ashtangahridaya chikitsastana gulma chikitsa adyaya 14 shloka number 35
2Intervention ArmDrugClassical(1) Medicine Name: Nalikera Ksheera , Reference: Bhavaprakasha, Route: Oral, Dosage Form: Khanda /Granules, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: Bhavaprakasha chapter 6 kritannavarga shloka 17-18
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Underweight subjects of all sexes of age 13 to 18 years.
2. BMI less than 18.5kg/𝑚2
3. Mid arm circumference less than 12.5cm.
4. Subject will be selected irrespective of profession, religion, caste and economic status.
5. Subjects willing to include this preparation in their diet 
 
ExclusionCriteria 
Details  1. Known cases of severe systemic illness
2. Congenital and hereditary problems
3. Hormonal deficiency
4. Diabetes mellitus, hypothyroidism
5. Subjects taking other nutritional supplements (vitamins and minerals). 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of nalikera ksheera khanda on BMI in underweight among people in the
age group of 13 to 18 years. 		 BMI will be assessed on 0th day and 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of nalikera ksheera khanda on mid arm circumference in underweight
among people in the age group of 13 to 18 years 		 Mid arm circumference will be assessed on 0th day and 45th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   06/11/2024 
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="1"
Days="15" 
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
    Response -  Analytic Code

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

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.anaghasankar@gmail.com].

  6. For how long will this data be available start date provided 10-02-2027 and end date provided 07-03-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
The study is to evaluate the effect of nalikera ksheera khanda in underweight. Study setting is OPD of Swasthavritta, Govt Ayurveda college Tripunithura. Study population is underweight  subjects of all sexes of age 13 to 18 years and BMI less than 18.5kg/𝑚2. Sample size is 30 and study period is 45 days. The body mass index and mid arm circumference will be assessed on 0th and 45th day. The data collected will be processed and conclusions will be made accordingly.
 
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