| CTRI Number |
CTRI/2024/12/078783 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment for Tamaka shwasa(Bronchial asthma) by panchakarma in Ayurveda. |
|
Scientific Title of Study
|
A Clinical study to Evaluate the effect of Virechana karma on Interleukin(Inflammatory markers) in Tamaka shwasa(Bronchial asthma) A Single Arm Study. |
| 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 SHRIMANT G CHAVAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Himalayiya Ayurvedic PG Medical College and Hospital Dehradun Uttarakhand |
| Address |
Out patient department
Department of Panchakarma
Room no 11
Himalayiya Ayurvedic PG Medical College and Hospital Dehradun Uttarakhand GRAM FATEHPUR TANDA, MAJRI Dehradun UTTARANCHAL 248140 India |
| Phone |
09916863633 |
| Fax |
|
| Email |
drshrimantgc.bc@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR PRADEEP GRAMPUROHIT |
| Designation |
PROFESSOR |
| Affiliation |
KLEUs Shri B M K Ayurveda Mahavidhyalaya and Researchcentre Shahapur Belgaum Karnataka |
| Address |
Out patient department
Department of Panchakarma
KLEUs Shri B M K Ayurveda Mahavidhyalaya and Researchcentre Shahapur Belgaum Karnataka
Belgaum KARNATAKA 590005 India |
| Phone |
09964144197 |
| Fax |
|
| Email |
pradeepgrampurohit@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR SHRIMANT G CHAVAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Himalayiya Ayurvedic PG Medical College and Hospital Dehradun Uttarakhand |
| Address |
Out patient department
Department of Panchakarma
Room no 11
Himalayiya Ayurvedic PG Medical College and Hospital Dehradun Uttarakhand GRAM FATEHPUR TANDA, MAJRI Dehradun UTTARANCHAL 248140 India |
| Phone |
09916863633 |
| Fax |
|
| Email |
drshrimantgc.bc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Himalayiya Ayurvedic PG Medical College and Hospital Gram Fatehpur tanda Majri via Doiwala Dehradun
District Dehradun
State Uttarakhand
Country India
Pin code 248140 |
|
|
Primary Sponsor
|
| Name |
Dr Shrimant G Chavan |
| Address |
Out patient department
Department of Panchakarma
Room no 11
Himalayiya Ayurvedic PG Medical College and Hospital Gram Fatehpur tanda Majri Via Doiwala Dehradun Uttarakhand |
| 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 Shrimant G Chavan |
Himalayiya Ayurvedic PG Medical College and Hospital |
Himalayiya Ayurvedic PG Medical College & Hospital
Gram- Fatehpur tanda, Via Doiwala, Dehradun, Uttarakhand
248140 Dehradun UTTARANCHAL |
09916863633
drshrimantgc.bc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J22||Unspecified acute lower respiratory infection. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chitrakadi vati, Reference: Charaka Chikitsa stana 17th chapter 96 sloka, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Intervention Arm | Procedure | - |  सà¥à¤¨à¥‡à¤¹à¤ªà¤¾à¤¨-करà¥à¤® | (Procedure Reference: Snehapana, Procedure details: Ghrita paana In chronological dose ) (1) Medicine Name: Murchita Gritha, Reference: Bhishajya ratnavali Sneha kalpana, Route: Oral, Dosage Form: Ghrita, Dose: 60(ml), Frequency: sos, Duration: 7 Days | | 3 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charaka kalpa stana, Procedure details: Virechana after Abhyanga & swedana) (1) Medicine Name: Trivrut avaleha, Reference: Charaka kalpa stana 7 chapter, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 60(g), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
• Chronicity less than 3-5 years.
• Mild to moderate grade of Bronchial asthma as per GINA.
• The patients having classical signs and symptoms of Tamakaswasa.
• PEFR 60% to 90% (Peak Expiratory flow rate).
• Patient who are fit for Virechana karma. |
|
| ExclusionCriteria |
| Details |
The patient with chronic respiratory diseases includes history of Tuberculosis, Pneumonia, Pulmonary effusion.
History of cases of COPD.
Other complicated respiratory disease having any organic lesion or any anatomical defect in airways.
History of Cardiac troubles or any other Pathology.
Severe and disoriented asthmatic conditions.
Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the levels of Interleukin 13 |
30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the levels of Interleukin 13 |
30days |
| Reduction in Symptoms |
23days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
16/01/2025 |
| 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="2" Months="6" Days="1" |
|
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
|
A respiratory disorder,
usually characterized by variable airflow limitation associated with airway
inflammation and remodelling. Bronchial asthma is a chronic inflammatory disease of
the airways. Tamaka
Shwasa is nearer to bronchial asthma identified with airway obstruction,
inflammation, producing extra mucus making it difficult to breath.The
prevalence of bronchial asthma is increasingly alarming now a days due to
increased air pollution, overcrowding, occupational conditions, stress and poor
hygiene. Current Global Initiative for Asthma (GINA) guidelines reported that the
prevalence is estimated to be 1 % to 18%. Studies have explored the potential role
of indoor and outdoor allergens, microbial exposure, seasonal changes, diet,
vitamins, breastfeeding, tobacco smoke, air pollution and obesity but no clear
consensus has emerged.
As per WHO 2019 health reports about 262 million people are suffering
from bronchial asthma. Annually
250000 deaths are attributed to asthma and its complications. It is estimated
that there may be an additional 100 million persons with asthma, by 2025. It
estimated that the prevalence of asthma in India is about 3% (30 million
patients), with a prevalence of 2.4% in adults aged >15 years and
between 4% and 20% in children.
The current therapies used
to treat Bronchial asthma are Corticosteroids, Anti-histamines and
bronchodilators.These medications are similar in their adverse effect profile. Nervousness,
Tachycardia, Palpitations, difficulty in sleeping are common adverse effects of
all these agents. Long-term treatment with these drugs may produce serious
adverse events. Cytokines are believed to have major role in inflammatory
process of the airways of the lung. Interleukins play essential roles in the activation and differentiation
of immune cells, as well as proliferation, maturation, migration, and adhesion.
Interleukins also have pro-inflammatory and anti-inflammatory properties. Interleukins
play important roles in the regulation of cytokines and signal transduction
during the Ig-E synthesis and play a pivotal role in the pathobiology of asthma.
The primary function of
interleukins is, therefore, to modulate growth, differentiation, and activation
during inflammatory and immune responses. The Interleukin-13 causes increased mucus
production by epithelial cells, increased collagen synthesis by fibroblasts and
inhibits pro-inflammatory cytokine production. Interleukin-13 works together
with Interleukin-4 in producing biologic effects associated with allergic
inflammation and in defence against parasites. Interleukins -13 is
mostly responsible for airway hyper-responsiveness, mucus overproduction, and bronchial
structural changes, Nitric oxide production, goblet cell metaplasia and
fibroblast proliferation, as well as elicits contractile responses and hyperplasia
of smooth muscle cells in the airways .The main Dosha involvement here is Kapha
& Vata and the Gati of Vata is Pratiloma. The Pratiloma gati of
Vayu must be brought to Anulomana. So, this pathogenesis is broken by Kapha
Vataghna and Ushna guna Aushadha. And to achieve this, Virechana Karma is the
process that does the Vata Anulomana and is Kapha-Vataghna. Secondly, Dusti of
Pitta Sthana is the root cause of this disease and for removal of this Dushta
Pitta Virechana Karma is said to the best procedure. Virechana Karma is
indicated in Tamaka Shwasa. These
cytokines exert key functions about inception, persistence and amplification of
bronchial inflammation and remodeling.
To test the hypothesis that serum IL-13 levels may be elevated in this cohort
of patients, a property that could make them possible candidate biomarkers in
determining asthma occurrence and severity. Serum Levels of IL-13, will be
determined by an enzyme-linked immune-sorbent assay (ELISA). So, till now the
studies to assess the effect of Virechana on inflammatory markers or on
Interleukins has not been carried out in Tamaka shwasa (Bronchial asthma). Virechana
karma as a prospective study.
The study will be intendent to Evaluate the effect of Virechana karma on
Interleukins (Inflammatory marker’s) in Tamaka shwasa (Bronchial Asthma)-
Single arm Clinical study.
|