A clinical trial to study the effect of preparation of gold (an ayurvedic preparation) in preventing diseases in children by promoting immunity

Phase 2/3

Recruiting

• Conditions: Healthy children of age group 6 to 12 years and not under any sort of medication for last 30 days and whose parents are ready to sign the informed accent form

• Registration Number: CTRI/2017/03/008183
• Lead Sponsor: Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan

Brief Summary

This study is a Randomized Controlled DoubleBlind Two arm Prospective Clinical Trial comparing the efficacy ofSwarnamrithaprashana [containing Swarnabhasma, Honey, Ghee, Yastimadhu (Glycyrrhiaglabra Linn.) Guduchi (Tinospora cordifolia. Wild), Shankhapushpi (Convolvuluspluricaulis. Choisy), Vaca          (Acoruscalamus Linn.), Jatamamsi (Nardostachys jatamansi DC.), Ashwagandha (Withaniasomnifera Dunal.), Pippali (Piper longum Linn.), Brahmi (Bacopa monnieri.Linn.)]/ Placebo (Sugar syrup) administered at a dose of one gelatinous capsule(0.4ml) daily for 30 days in 200 healthy children of 6 to 12 years agefulfilling the inclusion criteria. Efficacy of the trial drug and placebo willbe assessed on based on the changes in serum IgG and salivary IgA as primary outcomemeasures and changes in Atura bala and routine blood parameters as thesecondary outcome measures. BT and AT values will be taken on 0th day and 60thday of intervention respectively.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-31
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Healthy children of age group 6 to 12 years not under any sort of medication for last 30 days and whose parents are ready to sign the informed accent form and allow their children to participate in the clinical trial will be included.

Exclusion Criteria

Children with any acute or chronic systemic disorders will not be considered for the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in serum immunoglobulin G and salivary immunoglobulin A	60 days

Secondary Outcome Measures

Name	Time	Method
Changes in Aturabala (with specially designed format) and Blood routine (Hb%, TLC, DLC, ESR and RBC indices)	60 days

Trial Locations

Locations (1)

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan; 🇮🇳 Hassan, KARNATAKA, India

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan

🇮🇳Hassan, KARNATAKA, India

Dr Shailaja U

Principal investigator

9448816433

rao.shaila@gmail.com