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CTRI Number  CTRI/2021/08/035387 [Registered on: 04/08/2021] Trial Registered Prospectively
Last Modified On: 02/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To understand efficacy of Calcarea Phospharica 6x in improving health status of children with Malnutrition in age group of 1-5 years. 
Scientific Title of Study   Randomised Placebo Controlled Trial for the efficacy of Calcarea Phosphorica 6X in modifying Susceptibility of children with Malnutrition in age group 1-5 years 
Trial Acronym  MLN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR MIHIRKUMAR MAFATLAL PARIKH 
Designation  Professor and HoD- Organon of Medicine 
Affiliation  Smt. Malini Kishore Sanghvi Homoeopathic Medical College and Hospital 
Address  Smt. Malini Kishore Sanghvi Homoeopathic Medical College and Hospital, Room No-6, Department of Organon, Opp. Sumeru Navkar Tirth, Amod Road, Miyagam- Karjan, Dist Vadodara. Gujarat.

Vadodara
GUJARAT
391240
India 
Phone  9879521788  
Fax    
Email  drmihir10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR HITESH G PUROHIT 
Designation  Principal, Professor and HoD- Homeopathic Materia Medica 
Affiliation  Smt. Malini Kishore Sanghvi Homoeopathic Medical College and Hospital 
Address  Smt. Malini Kishore Sanghvi Homoeopathic Medical College and Hospital,Principal Office, 1 st Floor, Opp. Sumeru Navkar Tirth, Amod Road, Miyagam- Karjan, Dist Vadodara. Gujarat.

Vadodara
GUJARAT
391240
India 
Phone  9825592130  
Fax    
Email  drhiteshp@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR MIHIRKUMAR MAFATLAL PARIKH 
Designation  Professor and HoD- Organon of Medicine 
Affiliation  Smt. Malini Kishore Sanghvi Homoeopathic Medical College and Hospital 
Address  Smt. Malini Kishore Sanghvi Homoeopathic Medical College and Hospital,Room No-6, Department of Organon, Opp. Sumeru Navkar Tirth, Amod Road, Miyagam- Karjan, Dist Vadodara. Gujarat.

Vadodara
GUJARAT
391240
India 
Phone  9879521788  
Fax    
Email  drmihir10@gmail.com  
 
Source of Monetary or Material Support  
Lipoid Foundation 
 
Primary Sponsor  
Name  Lipoid Foundation 
Address  67067 Ludwigshafen, Germany 
Type of Sponsor  Other [Foundation working for children] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Mihirkumar M Parikh  Smt. Malini Kishore Sanghvi Homoeopathic Medical College and Hospital. Opp. Sumeru Navkar Tirth, Amod Road, Miyagam-Karjan. Dist Vadodara. Gujarat. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr MihirKumar M Parikh  Room No- 53-54, Department of Community Health Services  Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital. Amod Road,Karjan. Dist Vadodara.
Vadodara
GUJARAT 		 9879521788

drmihir10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E45||Retarded development following protein-calorie malnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Calcarea Phosphorica 6 X  Grades of Malnutrition- Green - 2 tablets once a day Yellow- 2 tablets twice a day Red - 2 tablets thrice a day This will be given for nine[9] months. 
Comparator Agent  Placebo  Grades of Malnutrition- Green- 2 tablets once a day Yellow- 2 tablets twice a day Red- 2 tablets thrice a day This will be continued for nine[9] months 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Malnourishment grade Green, yellow & Red as per the IAP guidelines will be included for the study. 
 
ExclusionCriteria 
Details  Known Children detected with congenital anomalies & other systemic disorders before or during the study will be excluded. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in the grades of malnutrition on the basis of the improvement in weight, height, head circumference and Mid upper arm circumference as given in IAP growth charts. Along with this the reduction in the repeated complaints due to malnutrition showing the modification in the susceptibility of the child.  Every 4 weeks for 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement in the general state of health by assessing co-morbidity due to undernutrition with help of CP 6X
2. Efficacy of CP6x in improving various opportunistic infection in malnourished children.
3. Knowing various types of Malnutrition in the Karjan block
4.Effect of CP 6x in various types of Malnutrition
 		 9 months 
 
Target Sample Size   Total Sample Size="266"
Sample Size from India="266" 
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   N/A 
Date of First Enrollment (India)   09/08/2021 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The research paper will be published once its analysis is done. 
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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included all research engines).

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2050?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Malnutrition is a big issue in developing and developed countries. The effect of malnutrition leads to stunting and various other medical issues due to various deficiencies. The children’s physical, mental growth is also affected. There are various reasons for Malnutrition which  may be different in various geographical areas. As we know, Malnutrition covers Under-nutrition and Over nutrition also. Here, we are going to address Under-nutrition in the children age group of 1-5 years as it is the most vulnerable age for the growth. These children are more susceptible for catching various opportunistic infections as their susceptibility is high. Mostly they catch up Upper respiratory Tract infections, Gastro-intestinal infection, Skin issues etc. Here, the study is to intervene these children by homeopathic medicine -Calcarea Phosphrica 6x [CP 6X] . A control group with placebo will give us understanding of efficacy of CP 6X. In detail study of the each child will be done to establish the efficacy of our medicine. 

The result will be assessed  by studying the reduction in the various infections and the measuring their growth by checking their weight, Height, Head circumference and Mid upper arm circumference. The standard is kept as growth chart laid down by Indian Association of Pediatrics. The assessment will be done after 9 months of intervention with comparison of control group.

The whole study is done in the Rural area around Karjan, District Vadodara in Gujarat.
 
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