| CTRI Number |
CTRI/2017/12/010845 [Registered on: 12/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
08/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see effect of some herbal drugs in the management of bronchial asthma (Tamaka Shwasa). |
|
Scientific Title of Study
|
“Comparative Study of Efficacy of ‘Shunthyadi Churna’ and ‘Parnasapanchaka Kwatha’ in the Management of Tamaka Shwasa with special reference to Bronchial Asthmaâ€. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Ram Kishor Joshi |
| Designation |
Professor & Head of Department |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Kayachikitsa, National Institute of Ayurveda, Jorawar Singh gate, Madhav Vilas palace, Amer road Jorawar Singh gate, Madhav Vilas palace, Amer road Jaipur RAJASTHAN 302002 India |
| Phone |
9414322297 |
| Fax |
|
| Email |
joshirk1964@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Ram Kishor Joshi |
| Designation |
Professor & Head of Department |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Kayachikitsa, National Institute of Ayurveda, Jorawar Singh gate, Madhav Vilas palace, Amer road Jorawar Singh gate, Madhav Vilas palace, Amer road Jaipur RAJASTHAN 302002 India |
| Phone |
9414322297 |
| Fax |
|
| Email |
joshirk1964@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shagufta Malhotra |
| Designation |
M.D. Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Kayachikitsa, National Institute of Ayurveda, Jorawar Singh gate, Madhav Vilas palace, Amer road Jorawar Singh gate, Madhav Vilas palace, Amer road Jaipur RAJASTHAN 302002 India |
| Phone |
9988646655 |
| Fax |
|
| Email |
shagufta.malhotra@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jorawar Singh gate, Madhav Vilas palace, Amer road jaipur, rajasthan, 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurved |
| Address |
National Institute of Ayurveda, Jorawar Singh gate, Madhav Vilas palace, Amer road, Jaipur |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Prof Ram Kishor Joshi |
National Institute of Ayurveda |
PG deptt of kayachikitsa, NIA, Jorawar Singh gate, Madhav Vilas palace, Amer road Jaipur RAJASTHAN |
9414322297
joshirk1964@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, NIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Tamaka Shwasa (Bronchial asthma), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Parnasapanchaka Kwatha |
Parnasapanchaka Kwatha in dose of 40 ml with Prakshepa of Pippali Churna (2gm) before meals twice a day orally for 30 days. |
| Comparator Agent |
Shunthyadi Churna |
Shunthyadi Churna in dose of 5gm with lukewarm water as Anupana before meals twice a day orally for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to give informed consent to participate for 30 days.
2.Patients of either sex with age between 18 to 60 years.
3.Patient with stable Bronchial Asthma (Tamaka Shwasa) (as per WHO GINA Guideline) for at least 6 weeks prior to trial.
4.Patient presents with signs & symptoms of Tamaka Shwasa (Bronchial Asthma) as mentioned in Ayurvedic and modern texts.
5.Symptomatic patient with positive test of reversibility (If possible).
|
|
| ExclusionCriteria |
| Details |
1.Patients with severe Bronchial Asthma.
2.Patients present with co-morbid disorders. (D.M., T.B., R.A., Carcinoma etc.).
3.Patients suffering from pulmonary diseases other than bronchial asthma like COPD, Pleural effusion, Pneumonia.
4.Patients with poorly controlled Hypertension (i.e. Systolic > 160 mm of Hg and Diastolic > 100 mm of Hg)
5.Patients with concurrent serious Hepatic disorder or Renal Disorders, severe Pulmonary Dysfunction, or any other systemic/serious complications like Cerebrovascular / Cardiovascular disease that may jeopardize the study.
6.H/o hypersensitivity to the trial drug or any of its ingredients.
7.Patients who have completed participation in any other clinical trial during the past six months.
8.Pregnancy or lactating women.
9.Any other condition which the Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients of either sex 18-60 yr old diagnosed with tamaka shwasa (Bronchial asthma) will be selected for relief in sign and symptoms |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess comparative efficacy of shunthyadi churna and parnasapanchaka kwatha in tamaka shwasa (Bronchial asthma) |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
06/11/2017 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Tamaka Shwasa is a type of Shwasa Roga in which patients feel excessive difficulty in breathing and drowning in dark. It may be defined as a Kapha-Vataja disease of Pranavahashrotasa, originating from Pitta Sthana, in which there is derangement of Prana Vayu, along with obstruction by Kapha; the vitiated Vayu attains Pratilomgati and the respiration is disturbed with feeling of tightness of chest, choking of neck or feeling of merging in darkness. It is analogous to Bronchial Asthma due to similarity in symptoms, pathogenesis, onset, causes and precipitating factors. Bronchial Asthma is characterized by chronic airway inflammation and increased airway responsiveness resulting in symptoms of wheeze, cough, chest tightness and dyspnoea. It is also functionally characterized by the airflow limitations which usually reverse spontaneously or with treatment. Current estimate suggest that 300 million people worldwide suffer from Asthma and an additional 100 million may be diagnosed with Asthma by 2025. According to WHO, by the year 2020, Asthma along with COPD will become the third leading cause of death. India has estimated 15-20 million asthmatics. The available treatment in modern medical science like Bronchodilators, Steroids even in the form of inhalers have made tremendous success in providing instant or symptomatic relief in Bronchial Asthma. But there is recurrent acute exacerbation with remissions and treatment has many side effects like nausea, vomiting, tremor and huskiness of voice. So, need of time is to go for herbal remedies and procedures which not only treat the above ailment but are cost effective, safe and reduces the episodes of relapse of the disease. Keeping this fact in mind, the clinical trial is proposed. A number of formulations have been mentioned in Ayurvedic classics for the treatment of Tamaka Shwasa. Vata and Kapha are the predominant Doshas involved in the pathogenesis of Tamaka Shwasa. The treatment must be of Vatahara and Kaphahara line along with the clearing of the passage of Pranavaha Srotas. Therefore, the drugs with the above said qualities are needed for relieving the symptoms of Tamaka Shwasa. Keeping all above points in mind, the two compound drugs Shunthyadi Churna and Parnasapanchaka Kwatha have been selected to know their effect in treating Tamaka Shwasa (Bronchial Asthma). The drugs are to be administered orally, so does not require any specific instrument or training as in case of inhalers and nebulizers. The contents of the drugs are cheap and easily available so the treatment cost is minimal and can be afforded even by poor patients. |