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CTRI Number  CTRI/2026/03/105094 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 02/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Natural Calcium for Bone and Muscle Health 
Scientific Title of Study   Evaluation of Safety and Efficacy of Innovative Natural Calcium Formulation for Bone & Muscle Health 
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 Shankara Nallikunja 
Designation  Clinical Neurologist 
Affiliation  Mallikatta Neuro Centre 
Address  Mallikatta Neuro Centre, Opposite Mallikatta Circle, Kadri, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845080925  
Fax    
Email  dr.shankaramnc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shankara Nallikunja 
Designation  Clinical Neurologist 
Affiliation  Mallikatta Neuro Centre 
Address  Mallikatta Neuro Centre, Opposite Mallikatta Circle, Kadri, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845080925  
Fax    
Email  dr.shankaramnc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Baidyanath Mishra 
Designation  Head Healthcare Research 
Affiliation  Dabur India Limited 
Address  1st floor, Dabur Research and Development Centre, Dabur India Limited, Plot no 22, Site 4, Sahibabad

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  911203378606  
Fax    
Email  baidyanath.mishra@dabur.com  
 
Source of Monetary or Material Support  
Dabur India Limited 
 
Primary Sponsor  
Name  Dabur India Limited 
Address  Dabur Research and Development Centre, Dabur India Limited, Plot no 22, Site 4, Sahibabad 
Type of Sponsor  Other [Ayurveda Healthcare] 
 
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 Shankara Nallikunja Dr Shobith Jogi  Mallikatta Neuro Centre  OPD department for ortho patients Neuro clinic, Opposite Mallikatta Circle, Kadri, Mangalore
Dakshina Kannada
KARNATAKA 		 9964340695

dr_shobith@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MANGALA INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M859||Disorder of bone density and structure, unspecified. Ayurveda Condition: ASTHIVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: DRDC/2023/045, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Provision of signed and dated informed consent prior to any study-specific procedures.
• Male & Female subjects between 18 to 80 years of age willing to participate in study & follow study procedures.
• Subjects with Reported Intolerance to oral calcium supplementation like constipation/ diarrhoea/ abdominal pain or cramping/nausea based on history.
• Confirmed osteoporosis/ osteopenia cases between this age group for either natural or drug induced.
• Peri or post-menopausal women with or without oestrogen therapy
• Neurological ailments with co-prescription of oral calcium
• Diabetic patients with OHD or insulin need of additional calcium intake.
• Non pregnant & non lactating females
• Parent/ Guardian of subject ready to provide written informed consent
 
 
ExclusionCriteria 
Details  • Participants who in Investigator’s opinion will not be able to follow study related procedures.
• Planning to get pregnant in near future.
• Pregnancy
• Cardiac failure of Grade II or more – (Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity as per NYHA
• Hepatic or renal failure – basis Liver or Renal Function Tests
• X-ray suggestive of Bone tumours
• Known history of Endocrine disorders: Hyperthyroidism, hypogonadism, or Cushing’s Syndrome
• Congenital disorders: Dysosteogenesis, Marfan’s syndrome.
• Prescence of any significant medical condition: Diabetes, Hypertension, or malignancy
• Chronic drug intake, particularly corticosteroids, methotrexate and heparin
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Change in serum calcium levels from baseline to end of study.
2. Change in Clinical symptoms of calcium deficiency like pain in back, bone, fatigue, numbness in finger.
3. Gastro-intestinal tolerability like acidity, abdominal flatulence, constipation, abdominal fullness
4. Changes in hypertension 		 Pre and Post treatment 
 
Secondary Outcome  
Outcome  TimePoints 
1. Product Acceptability, Palatability & Tolerability
2. Impact and positive impact in changes in Psychosomatic behaviours those visible in lower calcium in body like tolerability to stress, cognition, memory, psycho-stress
 		 pre and post treatment 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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/ Phase 3 
Date of First Enrollment (India)   16/03/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Current study is a clinical study of innovative ayurceutical formulation for bone and muscle health. Study will be conducted under supervision of Allopathic Doctor as investigator in subjects between 18 to 60 years of age and who will be followed up at monthly intervals. results of the study will be assessed basis relieving of symptoms and change in serum calcium level, improvement in quality of life from baseline to end of study.  
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