| 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 |
|
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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)] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | SYRUP CALCIMAX PLUS | Compositionm 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 | | 2 | Intervention Arm | Drug | Classical | | (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: - | | 3 | Intervention Arm | Procedure | - | 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 |
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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. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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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 |
|
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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
|
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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. |