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CTRI Number  CTRI/2026/01/100227 [Registered on: 02/01/2026] Trial Registered Prospectively
Last Modified On: 02/01/2026
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   Role of Nagabala Ghrita in Children with Ahthikshaya/Calcium Deficiency 
Scientific Title of Study   A Randomized Controlled Clinical Study to Evaluate the Effect of Nagabala Ghrita as Matra Basti and Oral Route in Children with Asthi Kshaya (Calcium Deficiency), Compared with Oral Calcium Supplementation 
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 Sudheer B R 
Designation  PhD Scholar 
Affiliation  Sri Sri College of Ayurvedic science and research Cuttack  
Address  OPD No- C8, Sri Sri College of Ayurvedic science and research hospital, Sri Sri University,Cuttack, Odisha-754006
Sri Sri College of Ayurvedic science and research hospital, Sri Sri University,Cuttack, Odisha-754006
Cuttack
ORISSA
754006
India 
Phone  9900175777  
Fax    
Email  sudheerbrao@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Durga Prasad Dash 
Designation  Professor and HOD 
Affiliation  Sri Sri College of Ayurvedic science and research Cuttack  
Address  Sri Sri College of Ayurvedic science and research hospital, Sri Sri University,Cuttack, Odisha-754006
Sri Sri College of Ayurvedic science and research hospital, Sri Sri University,Cuttack, Odisha-754006
Cuttack
ORISSA
754006
India 
Phone  9853435916  
Fax    
Email  dpd75@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Durga Prasad Dash 
Designation  Professor and HOD 
Affiliation  Sri Sri College of Ayurvedic science and research Cuttack  
Address  Sri Sri College of Ayurvedic science and research hospital, Sri Sri University,Cuttack, Odisha-754006
Sri Sri College of Ayurvedic science and research hospital, Sri Sri University,Cuttack, Odisha-754006
Cuttack
ORISSA
754006
India 
Phone  9853435916  
Fax    
Email  dpd75@rediffmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic science and research hospital, Sri Sri University,Cuttack, Odisha-754006 
 
Primary Sponsor  
Name  Dr Sudheer B R 
Address  OPD No- C8, Sri Sri College of Ayurvedic science and research hospital, Sri Sri University,Cuttack, Odisha-754006 
Type of Sponsor  Other [(Self)] 
 
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 Sudheer B R  Sri Sri College of Ayurvedic science and research hospital, Sri Sri University,Cuttack.  OPD No- C8, Sri Sri College of Ayurvedic science and research hospital, Sri Sri University,Cuttack, Odisha-754006
Cuttack
ORISSA 
9900175777

sudheerbrao@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) for Biomedical Research of Faculty og Health & Wellness of Sri Sri University, Cuttack  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: ASTHIKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-SYRUP CALCIMAX PLUSCompositionm CALCIUM-250MG, MAGNESIUM-75MG, VITAMIN D3-200IU, ZINC-2MG Route of administration- Oral Dose- 5 ML twice daily for all age groups included in the study Duration – 28 days
2Intervention ArmDrugClassical(1) Medicine Name: Nagabala ghrita, Reference: Charaka Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: -
3Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charaka Samhita, Procedure details: Procedure details: Poorva karma: Subjects will be asked to come for the treatment immediately after taking food, Sthanika abhyanga will be performed on the abdomen, buttocks and thighs for 20 minutes, followed by Nadi Sweda using Ushna jala for 10 minutes. Pradhana karma: participants will be asked to lie in the left lateral position with the left leg straight and the right leg flexed at the knee joint. Under aseptic precautions, the anus will be anointed with oil using a cotton swab , and the drug will be administered via a rubber catheter (number 6) attached to a syringe. Paschat karma: A gentle massage will be given over the abdomen, back and plantar region after the Basti administration.)
(1) Medicine Name: Nagabala Ghrita, Reference: Charaka Samhita, Route: Rectal, Dosage Form: Ghrita, Dose: 24(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1. Participants in the age group of 3 years- 6 years.
2. Participants of any gender, religion or socio-economic background.
3. Participants diagnosed with Asthi kshaya based on classical Ayurvedic symptoms and supported by relevant clinical and laboratory findings.
4. Participants with mild to moderate calcium deficiency confirmed by laboratory findings.
5. Participants whose parents or legal guardians provide written informed consent and agree to comply the treatment protocol. 
 
ExclusionCriteria 
Details  1. Participants below 3 years or above 6 years of age.
2. Participants with severe calcium deficiency requiring emergency medical intervention.
3. Participants with chronic systemic illnesses such as congenital bone disorders, renal disease, malabsorption syndrome, or metabolic disorders.
4. participants with a known history of hypersensitivity to any ingredients in the study formulations.
5. Participants currently undergoing any treatment that may interfere with calcium metabolism or bone health.
6. Participants who are unwilling or whose parents/guardians do not provide written informed
consent. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant clinical improvement in Asthi Kshaya and calcium deficiency parameters such as bone health indicators, serum calcium levels, and alleviation of associated symptoms.  0th, 8th, 28th, 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in growth-related anthropometric measurements. Generation of detailed clinical data regarding the Ayurvedic approach in calcium deficiency management. Better understanding of tolerability and acceptability of Ayurvedic interventions in pediatric care.  0th, 28th, 60th day 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   15/01/2026 
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="1"
Months="0"
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 - NO
Brief Summary  
1. The period of childhood is recognized as a phase of significant growth, wherein optimal growth is attained through a well-balanced diet and the absence of disease. Due to increased growth and metabolism, the nutritional requirements of children are higher compared with adults.
2. Achieving optimal growth requires a proper diet that ensures sufficient intake of both macronutrients and micronutrients. While macronutrients have received more attention, micronutrients should not be overlooked.
3. Micronutrient deficiencies affect an estimated two billion people, or almost one-third of the world’s population. Calcium, on the other hand, is at prevalence of deficiency, with 94% of the population at risk.
And in about 59.9% of urban school-going children and adolescents alone.
4. Children with strictly vegetarian diet and those who have low intake of diary supplements are especially at risk of calcium deficiency. In older children who are mostly attracted to Western diets which lacks dietary calcium, calcium supplements are required to meet bone mineral accretion requirements.
5. It was reported that intakes of about 900 mg/d led to calcium retention of about 172 mg/d [18] and that intakes of about 700 mg/d let to retentions of about 120 mg/day. There is a substantial variability in the amount of skeletal calcium accreted in this age range of 4 to 8 years.
6. Presently, calcium supplements are prescribed prophylactically in children to support healthy bone development and overall growth. There is a wide range of calcium supplements available in the market, each claiming various benefits but it is also important to monitor for its adverse effects on the digestive system like constipation, fatigue, dizziness, renal calculi etc.
7. Since Calcium and Phosphorus are major components of Asthi dhatu, Calcium deficiency can be considered as one of the major causes of Asthi dhatu Kshaya.
8. Dhatupratyaneeka Chikitsa with respect to Asthi Dhatu Kshaya includes Bastikarma, the use of Snigdha,guru, Madhura- tikta, Brihmana Dravyas including Ksheera, Ghrita etc.
9. In this context, Nagabala Ghrita, a classical formulation is a combination of drugs said to be Balya, Brihmana, Ojasya, Vali-Palityaghna, Varnya, Rasayana etc.6 The biological activities of the genus Grewia (Nagabala)are said to have high contents of Calcium and are extremely important for curing severe pain in bones and also help to increase the mobility of joints.
10. Calcimax plus suspension containing Calcium, Vitamin D, Zinc and Magnesium in the absorbable form and is a standard preparation used as a bone and joint health supplement in children. This study is an effort to compare the efficacy of Nagabala Ghrita as Matra Basti followed by Brihmana Sneha orally and Calcimax suspension in Asthi Kshaya with special reference to Calcium deficiency in children.
 
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