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Clinical Trials/CTRI/2022/03/041521
CTRI/2022/03/041521Not yet recruitingPhase 1/2

A clinical study to evaluate the effect of Ashwagandha Kshaar on Kaphaj kasa in pediatric age group.

Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur C G1 site in 1 country40 target enrollmentStarted: April 20, 2022Last updated:

Trial Snapshot

Phase
Phase 1/2
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
1.Kasa vega(Frequency of cough) reduced

Study Overview

Brief Summary

Physiologically Kapha dosha is predominant in balya-awastha, may cause various Kaphaj vyadhi such as Kphaj kasa. This is one of the most common disease that affect Pranvah shrotas and further health of the child. Acharya Charak has prescribed Ashwagandha kshaarin the management of Kapha avrudha marga Kasa. Present study is aimed to re-evaluate the effect of Ashwagandha Kshaar on Kaphaj Kasa (Productive cough). In this study subject will be advised for oral administration of Ashwagandha kshaar and dose of administration will be calculated based on Body Surface Area. Ashwagandha kshaar will be advised in viscous liquid formwith unequal amount of Madhu and Ghrita (ratio 3:1)for 20 days and follow-up will be done on every 10 days. Post treatment follow ups will be done in every 15 days for 2 months.Assessment will be done on the basis of subjective and objective criteria adopted for this study.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Open Label

Eligibility Criteria

Ages
5.00 Year(s) to 15.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Age group 5-15 years.
  • 2.Sex- both male and female.
  • 3.Patient with symptoms of Kaphaj Kasa.
  • 4.Patient with feeling of tiredness, body ache along with wheezing, shortness of breath.
  • 5.Subject willing to participate in study after signing consent.

Exclusion Criteria

  • 1.Children below 5 years and above 15 years.
  • 3.Chronic disorders like Tuberculosis, Heart Disease, COPD [Chronic Obstructive Pulmonary Disease], Pulmonary abscess, Carcinoma, Pleural effusion, Pneumothorax, Status asthmatics, Congenital and genetic malformations.
  • 4.Patient on long term medication (Steroids, etc) 5.Patient tested positive for Covid-19.

Outcomes

Primary Outcomes

1.Kasa vega(Frequency of cough) reduced

Time Frame: At baseline, 10th day and then every 15 day for the period of 2 months.

2.Nisthavati Ghanam Kapham (Productive cough) reduced

Time Frame: At baseline, 10th day and then every 15 day for the period of 2 months.

Secondary Outcomes

  • 1. Vaksha Sampurnamiv manyate [Feeling of mucus in chest region] relived(2. Kanthoplepa [Feeling of mucus coating in upper respiratory tract ] relived)

Investigators

Sponsor
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur C G
Sponsor Class
Government medical college

Study Sites (1)

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