| CTRI Number |
CTRI/2023/08/056276 [Registered on: 08/08/2023] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Clinical Study to Know the Efficacy of Ritu Shodhana and Dashamoola Haritaki Avaleha in the management of Tamaka Shwasa (Bronchial Asthma) |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Ritu Shodhana and Dashamoola Haritaki Avaleha in Tamaka Shwasa w.s.r 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 Vivekaradhya M |
| Designation |
PhD Scholar |
| Affiliation |
Rajiv Gandhi Education Society’s Ayurvedic Medical College, Hospital, PG & Ph.D. Research Centre |
| Address |
Department of Panchakarma.
Rajiv Gandhi Education Society’s Ayurvedic Medical College Hospital PG & Ph.D. Research Centre Ron.
Gadag
KARNATAKA
582209
India |
| Phone |
09164813230 |
| Fax |
|
| Email |
vivekaradhya32@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr I B Kotturshetti |
| Designation |
Principal & Professor, Department of Panchakarma |
| Affiliation |
Rajiv Gandhi Education Society’s Ayurvedic Medical College, Hospital, PG & Ph.D. Research Centre |
| Address |
Rajiv Gandhi Education Society’s Ayurvedic Medical College, Hospital, PG & Ph.D. Research Centre, Ron, Karnataka.
Gadag
KARNATAKA
582209
India |
| Phone |
07795303509 |
| Fax |
|
| Email |
dribkotturshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I B Kotturshetti |
| Designation |
Principal & Professor, Department of Panchakarma |
| Affiliation |
Rajiv Gandhi Education Society’s Ayurvedic Medical College, Hospital, PG & Ph.D. Research Centre |
| Address |
Rajiv Gandhi Education Society’s Ayurvedic Medical College, Hospital, PG & Ph.D. Research Centre, Ron, Karnataka.
Gadag
KARNATAKA
582209
India |
| Phone |
07795303509 |
| Fax |
|
| Email |
dribkotturshetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Education Society’s Ayurvedic Medical College, Hospital, PG & Ph.D. Research Centre, Ron, Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Vivekaradhya M |
| Address |
Rajiv Gandhi Education Society’s Ayurvedic Medical College, Hospital, PG & Ph.D. Research Centre, Ron, Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivekaradhya M |
Rajiv Gandhi Educational Societys Ayurvedic Medical College and Hospital, Ron, Gadag |
OPD No 08 and IPD Department of Panchakarma.
Rajiv Gandhi Educational Societys Ayurvedic Medical College and Hospital, Ron, Gadag
Gadag
KARNATAKA |
9164813230
vivekaradhya32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects (IEHS) Rajiv Gandhi Education Societys Ayurveda Medical College, Hospital and PG Centre, Ron Karnataka: 582209 |
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 | Procedure | - | vamana-karma/ pracCardanam, वमन-करà¥à¤®/ पà¥à¤°à¤šà¥à¤›à¤°à¥à¤¦à¤¨à¤®à¥ | (Procedure Reference: Charaka Chikitsa 17, Procedure details: Classical Vamana Karma Followed by Dashamoola Haritaki Avalehya)
(1) Medicine Name: Dashamoola Haritaki Avalehya, Reference: Astanga hridaya Chikitsa 17, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: od, Duration: 48 Days | | 2 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charaka Chikitsa 17, Procedure details: Classical Virechana Followed by Dashamoola Haritaki Avalehya)
(1) Medicine Name: Dashamoola Haritaki Avalehya, Reference: Astanga Hridaya Chikitsa 17, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: od, Duration: 48 Days |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with classical features of Tamaka Shwasa i.e Shwasa Krichrata, Ghurghuraka, Kasa, Peenasa etc.
Patients who are fit for Shodana (Vamana & Virechana Yogya).
Patients aged between 17-60 years
Patients with history of Tamaka Shwasa less than 5 years.
Peak flow meter Rate more than 80 L/min & less than 300 L/min |
|
| ExclusionCriteria |
| Details |
Patients with history of Tamaka Shwasa more than 5 years.
Asthma in pregnancy.
Acute condition of the patient, who requires oxygen inhalation.
Patients of tamaka swasa associated with COPD, Pulmonary tuberculosis, pulmonary effusion etc.
Patients suffering from other systemic diseases like DM, HTN, HIV, HbSAg. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the Symptoms of Tamaka Shwasa will be assessed using Asthma Control Test. |
0th Day, 30th Day, 6months, 12 months, 24 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in
Rhonchi
Peak Flow Meter Rate
Respiratory Rate
Total Leucocyte Rate
AEC Count |
0th day, 30th Day, 6months, 12 months, 24 months. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1 |
|
Date of First Enrollment (India)
|
12/08/2023 |
| 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="5"
Months="0"
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 - NO
|
|
Brief Summary
|
Tamaka Shwasa is a type of Shwasa roga affecting the Pranavaha Srotas. The cardinal symptom of tamaka swasa is difficulty in breathing. Due to its severity and high morbidity rate it is described as Sheegrapranaharini. The disease is Pittasamudbhava vyadi, characterized by obstruction of Prana vata by kapha dosha leading to further vitiation of vata resulting in upward movement or vimargagamana of vata resulting in difficulty in breathing and associated symptoms. Tamaka Shwasa in Ayurvedic classics seems to be identical with the description of Bronchial Asthma.
Bronchial asthma it is a common chronic inflammatory condition of the airways whose mechanism is not completely understood yet. Bronchial Asthma is characterized by the inflammation of airway, difficulty in breathing, cough, wheezing etc. the disease can affect all categories of people irrespective of age, and gender etc and it seems to cause serious impairment in the patient’s quality of life. It is a heterogeneous disease with interplay between genetic and environmental factors. About 300 million people are suffering from Asthma worldwide. In India overall prevalence of Bronchial Asthma in adults is 2.38 % adults.
In the context of treatment of tamaka swasa both shodhana and shamana is explained and the disease is said to be Yapya. He also explains that drug which has the properties of kapha-vatahara, vatanulomana and ushna veerya has to be used for the treatment of Tamaka swasa. Vamana karma is the best line of treatment for dooshita kapha & pitta which will be expelled out through urdhwamarga. Tamaka shwasa which is a kaphavataja vikara & pitta sthana samudbhavita is one of the indications for vamanakarma. Acharya Charaka has explained Virechana as the main line of treatment in Avegavastha of Tamaka Shwasa. According to Ayurveda each dosha will undergo Chaya, Prakopa and Prashama in different ritus. If the particular dosha is treated with Shodhana Chikitsa in its Prakopa Kala it does not cause the diseases or aggravation of symptoms of a particular disease. Hence here an attempt will be made to compare the efficacy of Vasanthika Ritu Vamana Karma and Sharth Ritu Virechana Karma followed by Dashamoola Haritaki Avaleha in Tamaka Shwasa. |