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Clinical Trials/CTRI/2011/12/002204
CTRI/2011/12/002204CompletedPhase 2

Pharmaceutical Standardization of Vyaghrihareetaki Avaleha and Granules and their effect on Tamaka Shwasa (Bronchial Asthma)

Institute for Post Graduate Teaching and Research in Ayurveda1 site in 1 country90 target enrollmentStarted: October 7, 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
1.Changes in the cardinal symptoms of Tamaka shwasa.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is an Open, Randomized, Controlled, Clinical study to evaluate the efficacy of Group A - Vyaghrihareetaki avaleha (jaggery based), Group B - Vyaghrihareetaki avaleha (sugar candy based), Group C - Vyaghrihareetaki granules (sugar candy based) in the management of Tamaka shwasa (Bronchial asthma). The primary outcome measures are Changes in signs and symptoms of Tamala shwasa, ACQ, ACT score, Respiratory rate, Breath holding time, PEFR changes before treatment and after 4 weeks.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
16.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients having signs and symptoms of Tamaka Shwasa as described in Ayurvedic classics.
  • •Mild persistent cases of Asthma (as per WHO GINA Guideline) of duration more than 6 months.
  • •Symptoms/exacerbation (Wheeze, cough and breathlessness) more than once a week but less than once a day in frequency.

Exclusion Criteria

  • •1.Age more than 60 years and below 16 years.
  • •2.Mild intermittent, Moderated persistent, severe persistent to severe Asthma.
  • •3.Dyspnoea resulting from other diseases like left ventricular failure, COPD (Chronic Bronchitis, Emphysema), upper respiratory tract obstruction, bronchiectasis, cases of tuberculosis, interstitial lung disease/occupational lung disease, tropical pulmonary eosinophilia & allergic bronchopulmonary aspergillosis etc.
  • •4.Patients having anaemia, pneumonia, tuberculosis, lung cancer, lung abscess and other such complicated conditions.
  • •conditions in which urination is markedly diminished or excessive were excluded.
  • •6.HIV positive cases.
  • •7.Pregnant/lactating mother.
  • •8.Patients having classical symptoms of Maha, Urdha, Chinna and Kshudra Shwasa.

Outcomes

Primary Outcomes

1.Changes in the cardinal symptoms of Tamaka shwasa.

Time Frame: 0, 4 weeks

2. Changes in ACQ and ACT score and PEFR.

Time Frame: 0, 4 weeks

Secondary Outcomes

  • Respiratory rate and Breath holding time(0, 4 weeks)

Investigators

Sponsor
Institute for Post Graduate Teaching and Research in Ayurveda
Sponsor Class
Research institution and hospital

Study Sites (1)

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