Healthy VolunteerSPPILOTNPNCT07724561
Suvarnaprashana Pilot Study in Healthy Nepali Children Aged 2-5 Years
A study testing Suvarnaprashana (Ayurvedic gold-based formulation) in people with Healthy Volunteer, run by National Ayurveda Research and Training Center.
Trial summary
Introduction This prospective, single-site, non-randomized, open-label controlled pilot study aims to generate preliminary evidence on the short-term safety and potential immunomodulatory effects of Suvarnaprashana (SP), a traditional Ayurvedic intervention involving daily oral administration of a gold-based… Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Suvarnaprashana (Ayurvedic gold-based formulation)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 27 Aug 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 2-5 years
- WHO Z-score between -2 and +2 standard deviations
- Normal complete blood count (CBC), liver function test (LFT), and renal function test (RFT)
- Written informed consent from parent or guardian
- Ability to adhere to study protocol
Who cannot join
- Immunodeficiency (congenital or acquired)
- Known hypersensitivity to gold, honey, or ghee
- History of severe allergic reactions
- Presence of any chronic illness or acute infection at screening
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Amit M Joshi, PhD contact
About this study
Official title: Safety and Preliminary Immunomodulatory Efficacy of Suvarnaprashana in Healthy Children Aged 2-5 Years: A Prospective, Open-Label, Randomized Controlled Pilot Study in Nepal
Introduction This prospective, single-site, non-randomized, open-label controlled pilot study aims to generate preliminary evidence on the short-term safety and potential immunomodulatory effects of Suvarnaprashana (SP), a traditional Ayurvedic intervention involving daily oral administration of a gold-based formulation (Suvarna Bhasma triturated with honey and ghee).
Study Objectives Primary objectives focus on safety (monitoring adverse events, serious adverse events, and biochemical markers) and exploratory immunological changes (white blood cell differentials, immunoglobulins IgA/IgM/IgG, T-cell subsets CD4+/CD8+, cytokine IL-4, and infection incidence). Secondary objectives include monitoring gastrointestinal problems and overall infection episodes via caregiver logs and clinical assessments.
Read more
Study Methods
This prospective, open-label, controlled pilot study in Nepal enrolls healthy children. Children receive Suvarnaprashana or control (no intervention/standard care). Data collected via parental illness diaries, anthropometry, clinical examinations, and questionnaires at baseline and follow-ups assess safety (adverse events) and efficacy (immunity and morbidity). Analysis uses descriptive stats and basic comparisons.
Expected Outcomes The pilot study anticipates demonstrating Suvarnaprashana as safe (low adverse events) with preliminary efficacy signals, including fewer illnesses and enhanced immunity in Nepali children versus controls. Results may justify larger trials and guide safe integration of this traditional practice into pediatric healthcare in Nepal.
Read the detailed description
Detailed DescriptionThis is a prospective, single-site, open-label, randomized controlled pilot study designed to evaluate the safety and preliminary immunomodulatory efficacy of Suvarnaprashana (SP) in healthy children aged 2-5 years in Nepal. Suvarnaprashana is an Ayurvedic formulation consisting of Good Manufacturing Practice (GMP)-certified Suvarna Bhasma (gold ash) triturated with honey and ghee. While traditionally used to enhance childhood immunity and development, robust clinical evidence is limited.Study Rationale:
Traditional Ayurvedic texts suggest that Suvarnaprashana may support immune resilience, cognitive development, and overall health in children. Modern safety data for Suvarna Bhasma and its components, along with preliminary studies, support further investigation in a controlled setting. This pilot study aims to provide initial safety data and detect early signals of immunomodulatory efficacy, which are essential before considering larger, definitive trials for integration into child health programs.Study Design and Participants:
The study will enroll 40 healthy children between 2 and 5 years of age, recruited from the Provincial Ayurveda Hospital in Bijauri, Dang, Nepal. Participants will be screened for eligibility using WHO growth charts, nutritional status, and laboratory criteria (normal CBC, liver, and renal function tests). Parental/guardian informed consent is required, and verbal assent will be sought from children aged 4 years or older.Randomization and Allocation:
Eligible children will be randomly assigned in a 1:1 ratio to either the intervention group (Suvarnaprashana plus standard care) or the control group (standard care only). Randomization will use a computer-generated, permuted block method, with stratification according to baseline risk factors (nutritional and perinatal status) to ensure group balance.Intervention:
Children in the intervention group will receive a weight-based daily oral dose of Suvarnaprashana (1-4 drops, each drop containing approximately 0.25 mg Suvarna Bhasma) for 30 days. The preparation is administered on an empty stomach each morning, ideally starting near the Pushya Nakshatra period, with a ±7 day window for practical feasibility. The formulation's quality is verified by GMP certification and independent laboratory testing (including ICP-MS for heavy metals). Caregivers receive training in dose administration and adherence is monitored through daily logs and weekly follow-up.Children in both groups continue to receive all routine childhood immunizations, growth monitoring, and standard healthcare as per Nepal's national guidelines. No placebo is used in the control group.Assessments and Outcome Measures:
Primary outcomes are safety (incidence and severity of adverse and serious adverse events, changes in biochemical parameters, and serum/urine gold levels) and exploratory changes in immunological markers (white blood cell differentials, immunoglobulins IgA/IgM/IgG, T cell subsets CD4+/CD8+, cytokine IL-4, and infection rates). Secondary outcomes include the number, type, duration, and severity of infection episodes and gastrointestinal symptoms, as captured by caregiver logs and clinical review. Baseline and end-of-study assessments involve laboratory tests and physical examinations. Weekly safety monitoring and clinical assessments are performed throughout the intervention period.Data Collection and Monitoring:
Data are captured using encrypted electronic case report forms (eCRFs) and structured symptom diaries maintained by caregivers. The Data Monitoring Committee, comprising a pediatrician, biostatistician, and ethicist, oversees trial safety, with interim analyses and stopping rules for excess serious adverse events (>10%). Study procedures follow Good Clinical Practice (GCP), national ethical guidelines, and the Declaration of Helsinki.Statistical Considerations:
As a pilot study, the sample size (n=40) is designed for feasibility and initial data collection, not for formal hypothesis testing. Analyses include descriptive statistics, intention-to-treat and per-protocol comparisons, and exploratory use of regression models to investigate trends in safety and immunological parameters. Effect sizes and confidence intervals will guide the design of future studies.Ethical Considerations and Community Engagement:
Written informed consent is obtained from all parents/guardians, and verbal assent is sought from children aged 4 years or older when appropriate. The study is approved by the Institutional Research Committee (IRC) of NARTC and the Nepal Health Research Council (NHRC). A community advisory board with local representation provides guidance to ensure cultural sensitivity, and all participant data are kept strictly confidential.Significance:
This study addresses the urgent need for evidence-based evaluation of traditional Ayurvedic interventions in child health, aligned with World Health Organization (WHO) strategies for traditional medicine. Results will inform the feasibility, safety, and potential immunological benefits of Suvarnaprashana in young children and provide a foundation for larger confirmatory trials and policy guidance in Nepal.
- Conditions
- Healthy Volunteer
- Being tested
- Suvarnaprashana (Ayurvedic gold-based formulation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suvarnaprashana (Ayurvedic gold-based formulation)Other
A traditional Ayurvedic formulation containing purified gold, honey, and clarified butter (ghee), administered orally once daily for 30 days in a weight-based dose.
| Study group | Role | What they receive |
|---|---|---|
| Suvarnaprashana Oral Administration | Experimental | Children aged 2-5 years in this arm receive daily oral Suvarnaprashana for 30 days. The formulation consists of GMP-certified Suvarna Bhasma (gold), honey, and ghee, administered in a weight-based dose (1-4 drops) each morning on an empty stomach. All participants also receive standard care including immunizations and health monitoring as per national guidelines. Adherence is monitored with caregiver logs and weekly clinical assessments. Receives: Other: Suvarnaprashana (Ayurvedic gold-based formulation) |
| Standard Care Only | No intervention | Children aged 2-5 years in this arm receive only routine childhood healthcare as per Nepal's national guidelines, including immunizations, growth monitoring, and illness management. No Suvarnaprashana or other investigational product is administered. Health outcomes and adverse events are monitored similarly to the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Count of participants who experienced at least one adverse event during the 8-week study period.
Measured: 8 weeks
Change in ALT (IU/L)
Mean difference in alanine aminotransferase (ALT) levels from baseline to week 8.
Measured: 8 weeks
Change in AST (IU/L)
Mean difference in aspartate aminotransferase (AST) levels from baseline to week 8.
Measured: 8 weeks
Change in Bilirubin (mg/dL)
Average change in serum bilirubin from baseline to week 8.
Measured: 8 weeks
Change in Creatinine (mg/dL)
Change in serum creatinine concentration from baseline to week 8.
Measured: 8 weeks
Change in Hemoglobin (g/dL)
Difference in hemoglobin concentration from baseline to week 8.
Measured: 8 weeks
Change in WBC Count (10³/μL)
Mean change in white blood cell count from baseline to week 8.
Measured: 8 weeks
Change in Platelet Count (10³/μL)
Mean change in platelet count from baseline to week 8.
Measured: 8 weeks
Change in Serum Gold (μg/L)
Difference in serum gold concentration from baseline to week 8.
Measured: 8 weeks
Change in Urine Gold (μg/L)
Difference in urine gold levels measured at baseline and week 8.
Measured: 8 weeks
Change in IgA (mg/dL)
Change in serum immunoglobulin A from baseline to week 8.
Measured: 8 weeks
Change in IgM (mg/dL)
Change in serum immunoglobulin M from baseline to week 8.
Measured: 8 weeks
Change in IgG (mg/dL)
Mean difference in serum immunoglobulin G from baseline to week 8.
Measured: 8 weeks
Change in CD4+ T Cell Count (cells/μL)
Change in CD4+ T lymphocyte count from baseline to week 8.
Measured: 8 weeks
Change in CD8+ T Cell Count (cells/μL)
Change in CD8+ T lymphocyte count from baseline to week 8.
Measured: 8 weeks
Change in IL-4 (pg/mL)
Difference in serum interleukin-4 levels from baseline to week 8.
Measured: 8 weeks
Number of Infection Episodes per Participant
Total number of infection episodes recorded per participant over the 8-week period.
Measured: 8 weeks
Secondary outcomes (6)
Number of Infection Episodes per Participant
Total number of clinically confirmed infection episodes (e.g., respiratory, urinary tract, or other) per participant during the study, as recorded in standardized caregiver logs and assessed at site visits.
Measured: 8 weeks
Duration of Infection Episodes (days)
Average length in days of each infection episode per participant, measured from onset to resolution, as documented in caregiver logs and confirmed at site visits.
Measured: 8 weeks
Severity of Infection Episodes (CTCAE Grade)
Maximum severity grade of each infection episode per participant, assessed using the Common Terminology Criteria for Adverse Events (CTCAE) during the 8-week study.
Measured: 8 weeks
Number of Gastrointestinal Events per Participant
Total number of gastrointestinal events per participant (e.g., diarrhea, vomiting, abdominal pain), recorded by caregivers and confirmed during clinic visits.
Measured: 8 weeks
Duration of Gastrointestinal Events (days)
Average number of days per gastrointestinal event per participant, as recorded in logs and confirmed at site visits.
Measured: 8 weeks
Severity of Gastrointestinal Events (CTCAE Grade)
Maximum severity grade for each gastrointestinal event per participant, graded according to CTCAE standards throughout the 8-week study period.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start27 Aug 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a randomized, parallel assignment, open-label design. Forty healthy children aged 2-5 years are randomly allocated in a 1:1 ratio to either receive daily Suvarnaprashana (Ayurvedic gold-based formulation) for 30 days or to a standard-care control group. Randomization is stratified by baseline risk factors to ensure balanced groups. No blinding is applied due to the nature of the intervention and pilot feasibility focus.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Ayurveda Research and Training Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Santosh Kumar Thakur, National Ayurveda Research and Training Center
- Investigators
- Amit Joshi, PhD, Study chair, National Ayurveda Research and Training Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724561
- Sponsor's protocol ID
- 300 - 2026
- Acronym
- SPPILOTNP
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to concerns about participant privacy, local regulatory requirements, and the pilot nature of the study. Data sharing may be reconsidered in future, larger studies if required by regulatory agencies and with appropriate safeguards.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary Immunomodulatory Efficacy of Suvarnaprashana in Healthy Children Aged 2-5 Years: A Prospective, Open-Label, Randomized Controlled Pilot Study in Nepal
- ClinicalTrials.gov ID
- NCT07724561
- Acronym / sponsor ID
- SPPILOTNP / 300 - 2026
- Conditions
- Healthy Volunteer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Ayurveda Research and Training CenterOther government
- Study start
- 27 Aug 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction This prospective, single-site, non-randomized, open-label controlled pilot study aims to generate preliminary evidence on the short-term safety and potential immunomodulatory effects of Suvarnaprashana (SP), a traditional Ayurvedic intervention involving daily oral administration of a gold-based formulation (Suvarna Bhasma triturated with honey and ghee).
Study Objectives Primary objectives focus on safety (monitoring adverse events, serious adverse events, and biochemical markers) and exploratory immunological changes (white blood cell differentials, immunoglobulins IgA/IgM/IgG, T-cell subsets CD4+/CD8+, cytokine IL-4, and infection incidence). Secondary objectives include monitoring gastrointestinal problems and overall infection episodes via caregiver logs and clinical assessments.
Study Methods
This prospective, open-label, controlled pilot study in Nepal enrolls healthy children. Children receive Suvarnaprashana or control (no intervention/standard care). Data collected via parental illness diaries, anthropometry, clinical examinations, and questionnaires at baseline and follow-ups assess safety (adverse events) and efficacy (immunity and morbidity). Analysis uses descriptive stats and basic comparisons.
Expected Outcomes The pilot study anticipates demonstrating Suvarnaprashana as safe (low adverse events) with preliminary efficacy signals, including fewer illnesses and enhanced immunity in Nepali children versus controls. Results may justify larger trials and guide safe integration of this traditional practice into pediatric healthcare in Nepal.
Detailed description
Detailed DescriptionThis is a prospective, single-site, open-label, randomized controlled pilot study designed to evaluate the safety and preliminary immunomodulatory efficacy of Suvarnaprashana (SP) in healthy children aged 2-5 years in Nepal. Suvarnaprashana is an Ayurvedic formulation consisting of Good Manufacturing Practice (GMP)-certified Suvarna Bhasma (gold ash) triturated with honey and ghee. While traditionally used to enhance childhood immunity and development, robust clinical evidence is limited.Study Rationale:
Traditional Ayurvedic texts suggest that Suvarnaprashana may support immune resilience, cognitive development, and overall health in children. Modern safety data for Suvarna Bhasma and its components, along with preliminary studies, support further investigation in a controlled setting. This pilot study aims to provide initial safety data and detect early signals of immunomodulatory efficacy, which are essential before considering larger, definitive trials for integration into child health programs.Study Design and Participants:
The study will enroll 40 healthy children between 2 and 5 years of age, recruited from the Provincial Ayurveda Hospital in Bijauri, Dang, Nepal. Participants will be screened for eligibility using WHO growth charts, nutritional status, and laboratory criteria (normal CBC, liver, and renal function tests). Parental/guardian informed consent is required, and verbal assent will be sought from children aged 4 years or older.Randomization and Allocation:
Eligible children will be randomly assigned in a 1:1 ratio to either the intervention group (Suvarnaprashana plus standard care) or the control group (standard care only). Randomization will use a computer-generated, permuted block method, with stratification according to baseline risk factors (nutritional and perinatal status) to ensure group balance.Intervention:
Children in the intervention group will receive a weight-based daily oral dose of Suvarnaprashana (1-4 drops, each drop containing approximately 0.25 mg Suvarna Bhasma) for 30 days. The preparation is administered on an empty stomach each morning, ideally starting near the Pushya Nakshatra period, with a ±7 day window for practical feasibility. The formulation's quality is verified by GMP certification and independent laboratory testing (including ICP-MS for heavy metals). Caregivers receive training in dose administration and adherence is monitored through daily logs and weekly follow-up.Children in both groups continue to receive all routine childhood immunizations, growth monitoring, and standard healthcare as per Nepal's national guidelines. No placebo is used in the control group.Assessments and Outcome Measures:
Primary outcomes are safety (incidence and severity of adverse and serious adverse events, changes in biochemical parameters, and serum/urine gold levels) and exploratory changes in immunological markers (white blood cell differentials, immunoglobulins IgA/IgM/IgG, T cell subsets CD4+/CD8+, cytokine IL-4, and infection rates). Secondary outcomes include the number, type, duration, and severity of infection episodes and gastrointestinal symptoms, as captured by caregiver logs and clinical review. Baseline and end-of-study assessments involve laboratory tests and physical examinations. Weekly safety monitoring and clinical assessments are performed throughout the intervention period.Data Collection and Monitoring:
Data are captured using encrypted electronic case report forms (eCRFs) and structured symptom diaries maintained by caregivers. The Data Monitoring Committee, comprising a pediatrician, biostatistician, and ethicist, oversees trial safety, with interim analyses and stopping rules for excess serious adverse events (>10%). Study procedures follow Good Clinical Practice (GCP), national ethical guidelines, and the Declaration of Helsinki.Statistical Considerations:
As a pilot study, the sample size (n=40) is designed for feasibility and initial data collection, not for formal hypothesis testing. Analyses include descriptive statistics, intention-to-treat and per-protocol comparisons, and exploratory use of regression models to investigate trends in safety and immunological parameters. Effect sizes and confidence intervals will guide the design of future studies.Ethical Considerations and Community Engagement:
Written informed consent is obtained from all parents/guardians, and verbal assent is sought from children aged 4 years or older when appropriate. The study is approved by the Institutional Research Committee (IRC) of NARTC and the Nepal Health Research Council (NHRC). A community advisory board with local representation provides guidance to ensure cultural sensitivity, and all participant data are kept strictly confidential.Significance:
This study addresses the urgent need for evidence-based evaluation of traditional Ayurvedic interventions in child health, aligned with World Health Organization (WHO) strategies for traditional medicine. Results will inform the feasibility, safety, and potential immunological benefits of Suvarnaprashana in young children and provide a foundation for larger confirmatory trials and policy guidance in Nepal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a randomized, parallel assignment, open-label design. Forty healthy children aged 2-5 years are randomly allocated in a 1:1 ratio to either receive daily Suvarnaprashana (Ayurvedic gold-based formulation) for 30 days or to a standard-care control group. Randomization is stratified by baseline risk factors to ensure balanced groups. No blinding is applied due to the nature of the intervention and pilot feasibility focus.
| Arm | Type | Receives |
|---|---|---|
| Suvarnaprashana Oral Administration | Experimental | Other: Suvarnaprashana (Ayurvedic gold-based formulation)Children aged 2-5 years in this arm receive daily oral Suvarnaprashana for 30 days. The formulation consists of GMP-certified Suvarna Bhasma (gold), honey, and ghee, administered in a weight-based dose (1-4 drops) each morning on an empty stomach. All participants also receive standard care including immunizations and health monitoring as per national guidelines. Adherence is monitored with caregiver logs and weekly clinical assessments. |
| Standard Care Only | No intervention | –Children aged 2-5 years in this arm receive only routine childhood healthcare as per Nepal's national guidelines, including immunizations, growth monitoring, and illness management. No Suvarnaprashana or other investigational product is administered. Health outcomes and adverse events are monitored similarly to the intervention group. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children aged 2-5 years
- WHO Z-score between -2 and +2 standard deviations
- Normal complete blood count (CBC), liver function test (LFT), and renal function test (RFT)
- Written informed consent from parent or guardian
- Ability to adhere to study protocol
Key exclusion criteria (4 listed)
- Immunodeficiency (congenital or acquired)
- Known hypersensitivity to gold, honey, or ghee
- History of severe allergic reactions
- Presence of any chronic illness or acute infection at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suvarnaprashana (Ayurvedic gold-based formulation)A traditional Ayurvedic formulation containing purified gold, honey, and clarified butter (ghee), administered orally once daily for 30 days in a weight-based dose. | Other | Suvarnaprashana Oral Administration |
Primary outcome
Number of Participants with Adverse Events
Time frame: 8 weeks
Count of participants who experienced at least one adverse event during the 8-week study period.
Change in ALT (IU/L)
Time frame: 8 weeks
Mean difference in alanine aminotransferase (ALT) levels from baseline to week 8.
Change in AST (IU/L)
Time frame: 8 weeks
Mean difference in aspartate aminotransferase (AST) levels from baseline to week 8.
Change in Bilirubin (mg/dL)
Time frame: 8 weeks
Average change in serum bilirubin from baseline to week 8.
Change in Creatinine (mg/dL)
Time frame: 8 weeks
Change in serum creatinine concentration from baseline to week 8.
Change in Hemoglobin (g/dL)
Time frame: 8 weeks
Difference in hemoglobin concentration from baseline to week 8.
Change in WBC Count (10³/μL)
Time frame: 8 weeks
Mean change in white blood cell count from baseline to week 8.
Change in Platelet Count (10³/μL)
Time frame: 8 weeks
Mean change in platelet count from baseline to week 8.
Change in Serum Gold (μg/L)
Time frame: 8 weeks
Difference in serum gold concentration from baseline to week 8.
Change in Urine Gold (μg/L)
Time frame: 8 weeks
Difference in urine gold levels measured at baseline and week 8.
Change in IgA (mg/dL)
Time frame: 8 weeks
Change in serum immunoglobulin A from baseline to week 8.
Change in IgM (mg/dL)
Time frame: 8 weeks
Change in serum immunoglobulin M from baseline to week 8.
Change in IgG (mg/dL)
Time frame: 8 weeks
Mean difference in serum immunoglobulin G from baseline to week 8.
Change in CD4+ T Cell Count (cells/μL)
Time frame: 8 weeks
Change in CD4+ T lymphocyte count from baseline to week 8.
Change in CD8+ T Cell Count (cells/μL)
Time frame: 8 weeks
Change in CD8+ T lymphocyte count from baseline to week 8.
Change in IL-4 (pg/mL)
Time frame: 8 weeks
Difference in serum interleukin-4 levels from baseline to week 8.
Number of Infection Episodes per Participant
Time frame: 8 weeks
Total number of infection episodes recorded per participant over the 8-week period.
6 secondary outcomes
Number of Infection Episodes per Participant
Time frame: 8 weeks
Duration of Infection Episodes (days)
Time frame: 8 weeks
Severity of Infection Episodes (CTCAE Grade)
Time frame: 8 weeks
Number of Gastrointestinal Events per Participant
Time frame: 8 weeks
Duration of Gastrointestinal Events (days)
Time frame: 8 weeks
Severity of Gastrointestinal Events (CTCAE Grade)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to concerns about participant privacy, local regulatory requirements, and the pilot nature of the study. Data sharing may be reconsidered in future, larger studies if required by regulatory agencies and with appropriate safeguards.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amit M Joshi, PhD contact
Amit Joshi, PhD study chair
National Ayurveda Research and Training Center
Questions about this trial
What is this clinical trial studying?
A study testing Suvarnaprashana (Ayurvedic gold-based formulation) in people with Healthy Volunteer, run by National Ayurveda Research and Training Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amit M Joshi, PhD (+977-9841091383, amitmanjoshi1981@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: 8 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.