| CTRI Number |
CTRI/2024/10/074674 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study on the management of Bronchial Asthma |
|
Scientific Title of Study
|
A Clinical Study on the Efficacy of Mahaswasari Loham in Tamaka Swasa with special reference to 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 Kummari Nikhitha |
| Designation |
Post graduate in KayaChikitsa |
| Affiliation |
Dr. BRKR Govt Ayurvedic college & Hospital |
| Address |
7-16, Kummariguda Village,
Kothur Mandal,
Rangareddy district
Department of Kaya Chikitsa, Division 2, Unit 2,
Dr. BRKR Government Ayurvedic Medical College and Hospital, Erragadda,
Hyderabad,
Telangana
500018
Hyderabad
TELANGANA
509325
India |
| Phone |
8919032928 |
| Fax |
|
| Email |
nikkinikhitha93070@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Laxmikantham |
| Designation |
Professor, MD Ayurveda, Department of Kaya Chikitsa |
| Affiliation |
Dr. BRKR Govt Ayurvedic Medical College and Hospital |
| Address |
Department of Kaya chikitsa,
Room no -2,
Division-2,
DR. BRKR Govt Ayurvedic medical college and Hospital
Department of Kaya chikitsa,
Room no -2,
Division -2,
DR. BRKR Govt Ayurvedic medical college and Hospital, Erragadda,
Hyderabad,
Telangana
500018
Hyderabad
TELANGANA
500018
India |
| Phone |
9989398463 |
| Fax |
|
| Email |
drlaxmikantham20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Laxmikantham |
| Designation |
Professor, MD Ayurveda, Department of Kaya Chikitsa |
| Affiliation |
Dr. BRKR Govt Ayurvedic Medical College and Hospital |
| Address |
Department of Kaya chikitsa,
Room no -2,
Division -2,
DR. BRKR Govt Ayurvedic medical college and Hospital
Department of Kaya chikitsa,
Room no -2,
Division -2,
DR. BRKR Govt Ayurvedic medical college and Hospital Erragadda
Hyderabad
Telangana
500018
Hyderabad
TELANGANA
500018
India |
| Phone |
9989398463 |
| Fax |
|
| Email |
drlaxmikantham20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. BRKR Govt Ayurvedic Medical College and Hospital, Erragadda, Hyderabad, Telangana, 500018, India |
|
|
Primary Sponsor
|
| Name |
Dr Kummari Nikhitha |
| Address |
Department of Kaya Chikitsa, Room no 2, Division 2, Dr. Brkr Government Ayurvedic Medical College and Hospital, Erragadda, Hyderabad, 500018, Telangana state, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Kummari Nikhitha |
Dr. BRKR Government Ayurvedic Medical College and Hospital |
Room no -2, Division 2, Department of Kaya Chikitsa, Dr. BRKR Govt Ayurvedic Medical College and Hospital, Erragadda, Hyderabad, 500018, Telangana State, India
Hyderabad
TELANGANA |
8919032928
nikkinikhitha93070@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe of Dr. BRKR Government Ayurvedic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J453||Mild 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: MahaSwasari Loham, Reference: Bhaishajya Ratnavali 13th Chapter, Hikka Swasa Chikitsa Prakaranam , 37-41 shloka, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Who are willing to participate in the study and agree for the consent sign
2.symptoms exacerbations cough, wheeze, dyspnea greater than a week
3.Mild persistant cases of asthma of duration more than 6months
4.Night symptoms twice per month but less than twice per week
5.FEVI greater than 80%
6.spo2 greater than 92%
7.Non smokers |
|
| ExclusionCriteria |
| Details |
1.Moderate and severe persistent asthma
2.Asthma due to other systemic origin
3.suffering from diabetes,cardiac asthma, status asthmatics,CVDs, autoimmune disorders.
4.HIV positive cases,pregnant women, lactating mothers
5.patients who need salbutamol inhaler daily
6.dyspnea due to other diseases like COPD, bronchiectasis, pulmonary tuberculosis, interstitial lung disease, occupational lung disease, malignancies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the frequency of episodes of Shortness of breath |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to reduce the signs and symptoms of bronchial Asthma |
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
14/10/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 14-10-2024 and end date provided 13-04-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Bronchial Asthma is a major non-communicable disease (NCD) & most common chronic obstructive lung disease affecting all age groups, which is characterized by chronic airway inflammation and increased airway hyper-responsiveness leading to symptoms of wheeze, cough, chest tightness and dyspnea. It is characterized functionally by the presence of airflow obstruction which is variable over short periods of time or is reversible with treatment. Asthma is included in the WHO Global action plan for the Prevention and Control of NCDs and the United Nations 2030 Agenda for Sustainable Development and to make progress towards Universal Health coverage. Bronchial Asthma is correlated with “Tamaka Swasa†based on the clinical features described in Ayurvedic Samhitas. “Swasati anena iti Swasahâ€(Shabda Kalpa Druma). In general, the word Swasa denotes respiration during physiological and pathologic conditions with normal and abnormal breathing pattern.‘Tamaka swasa’ is one among the five types of SWASA ROGA, it is described as Vata Kaphaja vikara mainly originating from Pittasthana and then manifested through Pranavaha Srotas. Due to nidanas (causative factors) Vata and Kapha gets prakopa in the Uras leading to vitiation of Pranavaha, Annavaha, Udakavaha srotas, later the obstructed Vayu travels in Pratiloma gati (reverse direction) and produces signs and symptoms of Tamaka swasa. During initial stages it is Sadhya (curable) and later it turns into Yapya vyadhi (palliable) if not treated properly. |