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Clinical Trials/CTRI/2025/08/092836
CTRI/2025/08/092836Not yet recruitingPhase 2

Comparative control clinical study to evaluate efficacy of Bibhitak (Terminalia bellirica) Churn vati in cough

Maharashtra University of Health Sciences,Nashik under the scheme of STRG1 site in 1 country72 target enrollmentStarted: August 20, 2025Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
72
Locations
1
Primary Endpoint
1) To study the Anti-inflammatory effect of Bibhitak Churna Vati in pharyngitis having Cough.

Study Overview

Brief Summary

Due to change in life style immunity of human being is decreasing spontaneously. At the same time pollution is becoming a big issue day by day this changes are affecting human health, cough, pharangitis, asthama, allergic bronchitis and respiratory disorders are found common in the society specially after Covid-19. There are so many formulations available to treat Cough in market. In Ayurveda simple remedies are mentioned to treat Cough, Asthama and respiratory disorders. As per Astanghridayama a single herb Bibhitak (Terminaliabellirica) is advice for the treatment of Cough, Asthama, Bronchitis. Bhibhitak (Terminalia bellirica) is cheapest medicine, freely available everywhere in India. Need to be tested for efficacy in Cough hence the purpose study is undertaken.We can control cough during the Purvaroopavastha to avoid further progress.The purvaroop mentioned in Ayurveda are pricking pain in the throat i.e.Shukpurnagalasyata, itching in the throat, changes in the voice, etc.Cough is common symptom seen due to pollution now a day. Many formulations are available to treat the same but they are not cost effective. Everyone is not able to afford it. Bibhitak churna vati is a specific formulation consisting of only one herb and that is why it is so cost effective to  afford by poor, needy patients. The drug is proven for its antimicrobial and anti inflammatory activity. The formulation is handy chewable.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

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

Inclusion Criteria

  • Male and females between 18 to 60 years of age (both inclusive)
  • Subject suffering from uncomplicated cough that does not require antibiotic treatment.
  • The onset time should not be more than 3 days.
  • Willing to sign informed consent.

Exclusion Criteria

  • Cough caused by bronchial asthma, tuberculosis, bronchiectasis, and other diseases that have been clearly diagnosed as chronic obstructive pulmonary disease and/or severe respiratory tract infection.
  • Patient with known current lung cancer and fibrosis of lung.
  • Patients with uncontrolled diabetes or hypertension.
  • Women during pregnancy or lactation or women who are preparing for pregnancy or lactation during the trial.
  • Subjects with known current serious illness, eg, multisystem failure, chronic liver disease, HIV, cancer, renal failure, serious cardiovascular disease.
  • Known allergy to any ingredient of study products.
  • Any other conditions, which in the opinion of the investigator/s, makes the patient unsuitable for enrollment or could interfere with his/her participation and completion of the study.

Outcomes

Primary Outcomes

1) To study the Anti-inflammatory effect of Bibhitak Churna Vati in pharyngitis having Cough.

Time Frame: 1 week

Secondary Outcomes

  • 1) To study soothing effect of Bibhitak Churna Vati in Cold.(2) To assess the effect of Bibhitak Churna Vati in dry and wet cough.)

Investigators

Sponsor
Maharashtra University of Health Sciences,Nashik under the scheme of STRG
Sponsor Class
Other [Health University]
Responsible Party
Principal Investigator
Principal Investigator

swapnil nanabhau done

Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03

Study Sites (1)

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