CTRI

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CTRI Number

CTRI/2025/05/086618 [Registered on: 09/05/2025] Trial Registered Prospectively

Last Modified On:

31/10/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Other (Specify) [Amastha Awaleha in Subjects With Bronchial Asthma]

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A study to check if Amastha Awaleha is safe and helpful for people with breathing problems

Scientific Title of Study

A Phase III, Open-Label, Two-Arm, Multi-Center, Comparative Study to Evaluate the Safety and Efficacy of Amastha Awaleha in Subjects With Bronchial Asthma

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
CTSRS/2503 Version No 1.0 Dated 30 Mar 2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Ms Arpita Malgi
Designation	Overall Coordinator and Team Lead Clinical Operations
Affiliation	Samahitha Research Solutions
Address	Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore KARNATAKA 560069 India
Phone	06364898825
Fax
Email	arpita@samahitha.com

Details of Contact Person
Scientific Query

Name	Ms Sathyavathi LM
Designation	HOD-Clinical Operations
Affiliation	Samahitha Research Solutions
Address	Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore KARNATAKA 560091 India
Phone	09739001749
Fax
Email	satyalm@samahitha.com

Details of Contact Person
Public Query

Name	Ms Arpita Malgi
Designation	Team Lead - Clinical Operations
Affiliation	Samahitha Research Solutions
Address	Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore KARNATAKA 560069 India
Phone	06364898825
Fax
Email	arpita@samahitha.com

Source of Monetary or Material Support

Maheshwari Pharmaceuticals (I) Ltd. A-48/14, site-4, Sahibabad Industrial area, Sahibabad, Ghaziabad, Uttar Pradesh, 201010

Primary Sponsor

Name	Maheshwari Pharmaceuticals (I) Ltd.
Address	A-48/14, Site-4, Sahibabad Industrial Area, Sahibabad, Ghaziabad, Uttar Pradesh, 201010
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sambashiva	Sri Lakshmi Super Speciality Hospital	#301, Room No.1, Ground Floor, 3rd Main Road, Old Extension, KR Puram, Bangalore Bangalore KARNATAKA	06364898825 drsambashiva.sl@gmail.com
Dr B N Satish	Upadhya Ayurveda Bhandar	Room No.1, Ground Floor, Near Srirampura MetroStation No. 38, MKK Road,Srirampura, Bangalore Bangalore KARNATAKA Bangalore KARNATAKA	6464467752 drbnsatish@yahoo.com

Details of Ethics Committee

No of Ethics Committees= 2
Name of Committee	Approval Status
Pranav Diabetes Center Ethics Committee	Approved
Pranav Diabetes Center Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:J459\|\|Other and unspecified asthma. Ayurveda Condition: TAMAKASVASAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Amastha Awaleha, Reference: NA, Route: Oral, Dosage Form: Kalka/ Paste, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -The intervention in this study is Amastha Awaleha, an Ayurvedic formulation administered orally at a dosage of 1–2 teaspoonfuls twice daily after food with lukewarm water, for a duration of 90 days. Subjects randomized to the intervention arm will receive Amastha Awaleha in combination with the Standard of Care (SOC) treatment for bronchial asthma
2	Comparator Arm (Non Ayurveda)		-	Standard of care	The comparator is the Standard of Care (SOC) alone, which includes the regular physician-prescribed medications for asthma management, such as inhaled corticosteroids and bronchodilators, administered as per standard clinical practice for a period of 90 days.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Age and Gender: Adults aged between eighteen and sixty years, of either gender. 2. Asthma Diagnosis: A documented clinical diagnosis of bronchial asthma for at least six months prior to enrollment. 3. Disease Severity: a. Mild to moderate asthma as defined by spirometry: i. Mild asthma: Post-bronchodilator FEV1 greater than or equal to eighty percent of the predicted value. ii. Moderate asthma: Post-bronchodilator FEV1 between sixty percent and eighty percent of the predicted value. b. An Asthma Control Questionnaire (ACQ) score in the range of one point zero to two point five, indicating partially controlled symptoms that require intervention. 4. Stability on Standard Care: Subjects must be on a stable regimen of standard of care for asthma management prior to enrollment. 5. Informed Consent: Ability and willingness to provide written informed consent before any study-related procedures. 6. Compliance: Willingness to comply with all the study procedures including scheduled visits and treatment administration.

ExclusionCriteria

Details

1. Severe Respiratory Conditions: Subjects with severe bronchiectasis, chronic obstructive pulmonary disease (COPD), or other significant respiratory disorders that might confound study results, (e.g., FEV1 less than 60 percent predicted).

2. Infectious Diseases: Presence of known chronic, contagious infectious diseases such as active tuberculosis, hepatitis B or C, or HIV.

3. Nasal or Airway Structural Abnormalities: Subjects with significant anatomical abnormalities (e.g., large nasal polyps or marked septal deviation) that could interfere with respiratory assessments.

4. Recent Participation in Other Trials: Participation in another clinical trial or use of any investigational product within a specified washout period prior to screening.

5. Psychiatric Conditions: A history of psychiatric illness that may compromise compliance or interfere with the interpretation of study outcomes.

6. Pregnancy and Lactation: Pregnant or lactating women, due to the unknown effects of the investigational product on fetal or neonatal development.

7. Other Medical Conditions: Any other condition deemed by the investigator to potentially interfere with study assessments or the safe participation of the subject.

Method of Generating Random Sequence

Other

Method of Concealment

Other

Blinding/Masking

Open Label

Primary Outcome

Outcome

TimePoints

1. Lung Function Improvement:
Change in spirometry parameters, specifically Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC), from baseline to Day 90. A clinically meaningful improvement is defined as an increase of at least 12% and 200 mL in FEV1 from baseline.
2. Symptom Reduction:
Change in the frequency and severity of asthma-related symptoms (e.g., cough, wheezing, chest tightness, and breathlessness) as recorded in subject diaries and assessed by clinician evaluations from baseline to Day 90.
3. Rescue Inhaler Usage:
Reduction in the frequency of rescue inhaler use over the 90-day treatment period,
indicating improved symptom management.

Day 0, 30, 60, 90

Secondary Outcome

Outcome	TimePoints
1. Asthma Control: Change in Asthma Control Questionnaire (ACQ) scores from baseline to Day 90. A decrease of 0.5 or more is considered the minimal clinically important difference. 2. Quality of Life: Improvement in quality of life as measured by the SF-36 health survey from baseline to Day 90.	Day 0, 30, 60, 90

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0"

Phase of Trial

Phase 3

Date of First Enrollment (India)

19/05/2025

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="4"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Background:
Bronchial asthma is a chronic inflammatory disease of the airways, characterized by bronchoconstriction, inflammation, and mucus hypersecretion. This condition leads to symptoms such as wheezing, coughing, chest tightness, and breathlessness, affecting the quality of life of individuals worldwide. In India, asthma remains a common chronic condition, significantly contributing to the national disease burden. Conventional treatments, including bronchodilators and corticosteroids, target asthma symptoms and inflammation but can lead to long-term side effects, prompting interest in complementary and alternative therapies.

Amastha Awaleha is a proprietary Ayurvedic formulation developed by Maheshwari Pharmaceuticals, containing over 30 standardized herbal ingredients. These ingredients, such as Vasa (Adhatoda vasica), Kantakari (Solanum xanthocarpum), and Yashti Madhu (Glycyrrhiza glabra), are known for their bronchodilatory, anti-inflammatory, and immune-enhancing properties. Given the limitations of long-term conventional therapies, Amastha Awaleha may offer an integrative approach to asthma management.

Brief Summary:
This Phase III open-label, multi-center clinical trial aims to evaluate the safety and efficacy of Amastha Awaleha as an adjunct to Standard of Care (SOC) in subjects with mild to moderate bronchial asthma. The study will enroll approximately 100 subjects aged 18–60 years and assess whether the addition of Amastha Awaleha to conventional therapy can improve lung function, reduce asthma symptoms, and enhance quality of life over a 90-day period. The study hypothesizes that Amastha Awaleha, when combined with SOC, will lead to superior outcomes compared to SOC alone.

Purpose of the Study:
The purpose of this study is to evaluate the efficacy and safety of Amastha Awaleha, a proprietary Ayurvedic formulation, when used as an adjunct to Standard of Care (SOC) in subjects with mild to moderate bronchial asthma. The study aims to determine whether the addition of Amastha Awaleha can improve lung function, reduce asthma symptoms, and enhance overall quality of life compared to SOC alone.