| CTRI Number |
CTRI/2019/07/020213 [Registered on: 16/07/2019] Trial Registered Prospectively |
| Last Modified On: |
16/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO OBSERVE THE EFFECT OF AYURVEDIC MEDICINE FOR THE TREATMENT OF BRONCHIAL ASTHMA (TAMAKA SHWASA) |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF AGASHTYA HARITAKI RASAYANA AND APAMARGA KSHARA IN THE MANAGEMENT OF MILD STABLE BRONCHIAL ASTHMA (TAMAK SHWASA) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR HARBANS SINGH |
| Designation |
Research Officer (Ay), Scientist-2 |
| Affiliation |
CENTRAL AYURVEDA RESEARCH INSTITUTE FOR RESPIRATORY DISORDERS |
| Address |
Clinical Research Unit
Room No217
MOTI BAGH ROAD
Patiala
PUNJAB
147001
India |
| Phone |
9501248820 |
| Fax |
0175-2223663 |
| Email |
dr.harbans@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HARBANS SINGH |
| Designation |
Research Officer (Ay), Scientist-2 |
| Affiliation |
CENTRAL AYURVEDA RESEARCH INSTITUTE FOR RESPIRATORY DISORDERS |
| Address |
Clinical Research Unit
Room No 217
MOTI BAGH ROAD
Patiala
PUNJAB
147001
India |
| Phone |
9501248820 |
| Fax |
0175-2223663 |
| Email |
dr.harbans@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR HARBANS SINGH |
| Designation |
Research Officer (Ay), Scientist-2 |
| Affiliation |
CENTRAL AYURVEDA RESEARCH INSTITUTE FOR RESPIRATORY DISORDERS |
| Address |
Clinical Research Unit
Room No217
MOTI BAGH ROAD
Patiala
PUNJAB
147001
India |
| Phone |
9501248820 |
| Fax |
0175-2223663 |
| Email |
dr.harbans@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan
61-65, Institutional Area, Opposite D-Block, Janakpuri,
New Delhi-110058
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR HARBANS SINGH |
Central Ayurveda Research Institute for Respiratory Disorders |
Department of Clinical Research Room No. 217 Moti Bagh Road
Patiala
PUNJAB |
9501248820
0175-2223663
dr.harbans@rediffmail.com |
| Vd KAVITA VYAS |
Regional Ayurveda Research Institute for Nutritional Disorders |
Department of Clinical Research Room No.3 Jaral Pandoh
Mandi
HIMACHAL PRADESH |
9888552911
01905-222857
kavitakrishu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Central Ayurveda Research Institute for Respiratory Disorders Moti Bagh Road Patiala Punjab 147001 |
Approved |
| Institute Ethics Committee Regional Ayurveda Research Institute for Nutritional Disorders, Jaral Pandoh, Mandi Himachal Pradesh-175124 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J453||Mild persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Agashtya Haritaki Rasayana (AFI -I, API-II; Vol. IV) |
Dose:10 gms twice daily
Dosage form:Avaleha
Route of Administration:Oral
Time of Administration : Twice a day in empty Stomach
Anupana:Lukewarm Water
Packing form:Pet Jar
Duration of therapy:12 weeks
|
| Intervention |
2.Apamarga Kshara (AFI-I, API-II; Vol. I) |
Dose:250 mg twice daily
Dosage form :Powder
Route of Administration:Oral
Time of Administration: Twice a day along with 10gm of Agashtya Haritaki rasayana
Packing form :Pet Bottle
Duration of therapy:12 weeks
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex with age between 18 to 60 years.
2.Diagnosed cases of the mild predominant or persistent stable Bronchial Asthma (Tamaka Shwasa) (as per GINA Guideline)
(Stable asthma controller therapy dose i.e no changes in regular anti-asthma medication & Symptoms: ≤ 2 days/week; Night time awakenings: ≤ 2 times/month; Interference with normal activities: None; Short-acting β2-agonist use for symptom control: ≤ 2 days/week; for 3 months prior to enrolment).
3.FEV1 >80% of the predicted value
4.Patients willing to participate and written consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients with FEV1 < 80% of the predicted value.
2.Patients with uncontrolled Diabetes Mellitus having HbA1C > 8%
3.Patients who have history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
4.Symptomatic patients with clinical evidence of Heart failure
5.Known cases of HIV and AIDS.
6.Known cases of malignancy
7.Patient taking participation in any other clinical trial.
8.Women who are planning for conception / pregnant or lactating.
9.Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease (COPD)
10.H/o hypersensitivity to any of the trial drugs or their ingredients
11.Any other condition which the Investigator thinks may jeopardize the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in Asthma Control Questionnaire (ACQ)
2. Frequency of need for control medication
|
On baseline,14th day,28th day, 42th day, 56th day, 70th day, 84th day and 98th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Any improvement in FEV1
2.Changes in serum CRP, IgE
3.Frequency of need for rescue medication
|
On baseline,14th day,28th day, 42th day, 56th day, 70th day, 84th day and 98th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Bronchial asthma is a
chronic inflammatory disorder of the airway and the most common distressing
disease affecting 3-5% of the total population [1]. In 1998 the national asthma
campaign estimated the prevalence of diagnosed asthma cases in India to be 3.4
million. [2] In the field of allergic respiratory diseases, several indigenous
drugs have been successfully tested and used as conservative therapy in asthma.
Ayurveda, the great indigenous system of medicine of India is a complete
healthcare system and deals with the preventive and curative aspects of the
many diseases. Ayurveda refers to bronchial asthma as Tamaka Swasa and
contributes several modalities of treatment for the same.[3] Among all the
treatment modalities polyherbal combinations are said to be well-accepted, safe
and effective in asthma. [4] No satisfactory management is not available in
conventional therapy to provide a adequate remedy of this disease. In the
present study, the drugs like Agashtya Haritaki Rasayana (API
Part II, Vol-IV) and Apamarga Kshara (API Part II, Vol-I) have been
taken. Both the drugs have been used for Tamaka Swasa effectively.
Therefore both the above drugs are taken into the study with the hypothesis
that, to act effectively for the proper Samprapti vighatana, by
alleviating the involved dosha. |