| CTRI Number |
CTRI/2025/10/095679 [Registered on: 07/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"A Study to Compare the Effect of Herbal Nebulization Therapies and Herbal Powder in Children with Bronchial Asthma" |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON THE EFFICACY OF BHARANGIMOOLA ARKA FOR NEBULIZATION WITH VIBHEETAKI CHOORNA INTERNALLY AND TAMBOOLA PATRA ARKA FOR NEBULIZATION WITH VIBHEETAKI CHOORNA INTERNALLY IN THE MANAGEMENT OF BRONCHIAL ASTHMA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NAVANEETH KRISHNAN N |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
VAIDYARATNAM AYURVEDA COLLEGE,THRISSUR,KERALA |
| Address |
DEPT OF KAYACHIKITSA, ROOM NO 1,OP BLOCK
VAIDYARATNAM AYURVEDA COLLEGE,THRISSUR,KERALA
Thrissur
KERALA
680306
India |
| Phone |
8547012244 |
| Fax |
|
| Email |
drnavaneethkrishnan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AMITABH SINGH |
| Designation |
PROFESSOR |
| Affiliation |
DESHBHAGAT AYURVEDIC COLLEGE AND HOSPITAL |
| Address |
DEPT OF KAYACHIKITSA,DESHBHAGAT AYURVEDIC COLLEGE AND HOSPITAL,MANDHI,GOBINDGARH,PUNJAB,INDIA
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
9815526868 |
| Fax |
|
| Email |
asinghay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NAVANEETH KRISHNAN N |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
VAIDYARATNAM AYURVEDA COLLEGE,THRISSUR,KERALA |
| Address |
DEPT OF KAYACHIKSTA,ROOM NO 1,OP BLOCKVAIDYARATNAM AYURVEDA COLLEGE,THRISSUR,KERALA
Thrissur
KERALA
680306
India |
| Phone |
8547012244 |
| Fax |
|
| Email |
drnavaneethkrishnan@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPT OF KAYACHIKITSA,ROOM NO 1,OP BLOCK,VAIDYARATNAM AYURVEDA COLLEGE HOSPITAL,OLLUR,THRISSUR,KERALA,INDIA,680306 |
|
|
Primary Sponsor
|
| Name |
DR NAVANEETHRISHNAN N |
| Address |
NEDIYAPARAMBU MANA,VENKITANGU,THRISSUR |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR NAVANEETH KRISHNAN N |
DEPT OF KAYACHIKISTA,ROOM NO 1,OP BLOCK,VAIDYARATNAM AYURVEDA COLLEGE,THRISSUR,KERALA |
VAIDYARATNAM AYURVEDA COLLEGE,THRISSUR,KERALA,INDIA,680306
Thrissur
KERALA |
08547012244
drnavaneethkrishnan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: BARANGI MOOLA ARKA, Reference: ARKA PRAKASHA, Route: Nasal, Dosage Form: Arka, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: Yes(details: -SALINE), Additional Information: -INTERNALLY VIBHEETHAKI CHOORNA WITH HONEY 3 GMS 4 TIMES A DAY | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: TAMBOOLA PATRA ARKA, Reference: ARKA PRAKASA, Route: Nasal, Dosage Form: Arka, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: Yes(details: -SALINE), Additional Information: -INTERNNALY VIBHEETHAKI CHOORNA WITH HONEY 3 GMS 4 TIMES A DAY |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of mild or moderate bronchial asthma according to GINA criteria.
Aged between 18-65 years.
Participants with an FEV1 (Forced Expiratory Volume in one second) ranging from
49% to 79%.
Participants exhibiting common symptoms such as wheezing, difficulty breathing,
chest tightness, and coughing.
Participants willing to provide informed consent for participation in the study. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the severity and frequency of cough, wheezing, and dyspnea in bronchial asthma patients |
BASE LINE,DAY 14,DAY 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparative efficacy between the two treatment groups (Bharangimoola Arka vs.
Tamboola Patra Arka). |
BASELINE,DAY 14,DAY 28 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Bronchial Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation. It is a clinical syndrome of recurrent attacks of expiratory dyspnea occurring in paroxysm and produced by generalized airway obstruction which is sufficiently reversible to give both subjective and objective relief of symptoms either spontaneously or by therapy. Acute exacerbation of bronchial asthma is characterized by episodes of recurrent wheeze, breathlessness, chest tightness and cough particularly at night or early morning. Tamaka swasa is one among the five verities of swasa roga produced due to the vitiation of kapha and vata dosha, along with the involvement of rasa dhatu in pranavaha srotas. On analysis of the symptoms of asthma it is more or less comparable to Tamaka swasa mentioned in Ayurveda classics. Inhalation therapy is the novel approach in Bronchial Asthma. Despite advancements in pharmacological treatments such as bronchodilators and corticosteroids, asthma management remains challenging for a significant portion of the patient population, with issues related to long-term medication use, side effects, and incomplete symptom control. These challenges have prompted the exploration of alternative and complementary therapies, particularly in the realm of Traditional Medicine, such as Ayurveda. In Ayurvedic medicine, respiratory disorders like asthma are often treated using a holistic approach that incorporates herbal formulations, dietary changes, and lifestyle modifications. Bharangimoola Arka (extracted from Clerodendrum serratum) and Tamboola Patra Arka (made from Betel Nut leaves) are two such formulations with established efficacy in managing respiratory conditions. These herbal therapies are believed to possess bronchodilator, anti-inflammatory, and expectorant properties, making them potentially beneficial in the treatment of asthma. When used as a nebulization therapy, these formulations may directly deliver therapeutic compounds to the respiratory tract, helping alleviate airway constriction and inflammation. Additionally, Vibheetaki Choorna (a powder of Terminalia bellerica) is widely used in Ayurveda for its anti-inflammatory, immune-modulating, and antioxidant properties. Its internal consumption in conjunction with nebulization therapy is believed to enhance the overall effectiveness in managing chronic respiratory diseases like asthma by strengthening the lungs and reducing recurrent exacerbations. This study aims to compare the efficacy of Bharangimoola Arka and Tamboola Patra Arka when used for nebulization therapy in combination with Vibheetaki Choorna taken internally, in the management of Bronchial Asthma. By evaluating both formulations through clinical trials, this research seeks to establish their therapeutic potential and scientific validation in the context of modern medicine. |