| CTRI Number |
CTRI/2022/10/046253 [Registered on: 07/10/2022] Trial Registered Prospectively |
| Last Modified On: |
06/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know the effect of Shunti arka Nebulization and shunti varti Dhumapana in Bronchial Asthma. |
|
Scientific Title of Study
|
To evaluate the effect of Shunti Arka Nebulization and Dhumapana in Tamakashwasa w.s.r to Bronchial Asthma - A comparative clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amrutha D C |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic Medical College, Bengaluru |
| Address |
Second year PG scholar
Department of PG studies in Panchakarma
Government Ayurvedic Medical college, Dhanwantari road. Bengaluru.
Bangalore
KARNATAKA
560009
India |
| Phone |
9964888984 |
| Fax |
|
| Email |
amruthadc01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananta S Desai |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurvedic Medical College, Bengaluru |
| Address |
Department of PG studies in Panchakarma
Government Ayurvedic Medical college, Dhanwantari road. Bengaluru.
Bangalore
KARNATAKA
560009
India |
| Phone |
9448185896 |
| Fax |
|
| Email |
anantdesai30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananta S Desai |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurvedic Medical College, Bengaluru |
| Address |
Department of PG studies in Panchakarma
Government Ayurvedic Medical college, Dhanwantari road. Bengaluru.
Bangalore
KARNATAKA
560009
India |
| Phone |
9448185896 |
| Fax |
|
| Email |
anantdesai30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic Medical College and Hospital, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr Amrutha D |
| Address |
Second year PG scholar
Department of PG studies in Panchakarma
Government Ayurvedic Medical College, Dhanwantari road, Bengaluru - 560009 |
| 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 Amrutha D C |
Government Ayurveda Medical college and hospital, Bengaluru-09 |
OPD-6,IPD
Department of PG studies in Panchakrama
Government Ayurveda Medical College,Dhanwantari road, Bengaluru - 560009
Bangalore
KARNATAKA |
9964888984
amruthadc01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, GAMC Bangalore |
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 | - | dhUmapAnam, धूमपानमॠ| (Procedure Reference: charaka samhita, Procedure details: Purvakarma -Sthanika (parshwa and prista) abhyanga with brihat saindavadi taila followed by nadi sweda with dashamoola quatha
Pradhana karma - Patient will be made to sit comfortably on chair, then prepared shunti varti is dipped in Sneha (murchita gritha), ignited and will be kept in dhumayantra.
Patient will be advised to inhale the Dhuma from mukha and exhale through mukha
repeat same for 3 times.
Paschat karma - Patient will be advised to do kavala with saindhava jala. And will be )
(1) Medicine Name: Shunti, Reference: Bhavaprakasha Nighantu, Route: Oral, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: bd, Duration: 5 Days | | 2 | Comparator Arm | Procedure | - | dhUmapAnam, धूमपानमॠ( Modified) | (Procedure Reference: charaka samhita, Procedure details: Nebulization is considering as modified Dhumapana.
5ml of shunti arka will be administering through nebulization. twice in a day within gap of 8 hours for 5 consecutive days.
while during procedure patient will be advised for nasal and oral breathing.)
(1) Medicine Name: shunti arka, Reference: arka prakasha, Route: Oral, Dosage Form: Arka, Dose: 5(ml), Frequency: bd, Duration: 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Lakshanas of vegakaleena tamakashwasa
2.Signs and symptoms bronchial asthma (mild to moderate condition acc to GINA parameters)
3.20-60 years of age
4.PEF rate: 60-90%
5.Spirometry (FEV): 60-80%
|
|
| ExclusionCriteria |
| Details |
1.PEFR - <60%
2.Spirometry <60%
3.H/o Cardiac involvement, Cyanosis
4.Any anatomical defect in airway and other complicated Respiratory disorders like TB, Emphysema, Chronic airway limitation
• Uncontrolled Diabetes mellitus and Hypertension
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in the symptoms of vegakaleena tamakashwasa
• Shwasa krichrata (difficulty in breathing)
• Ghurghuruka (wheezing)
• Kasa with kaphastheevana (cough with expectoration)
• Nocturnal waking
|
Before treatment - 1st day
After treatment - 5th day
follow up - 12th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• PEF
• Spirometry
• Respiratory rate
• Pulse rate
|
Before treatment - 1st day
After treatment - 5th day
follow up - 12th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2022 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
Tamakashwasa is one such disease of pranavaha strotas caused due to vitiation of vatakapha dosha, producing symptoms like peenasa, ghurghuruka shabda, atiteevravega shwasa, pranaprapeedaka kasa etc. Classics have explained the management with the help of vamana, virechana, dhumapana, sweda and oral medications. On observing the breathing pattern, pathological changes and clinical features, tamakashwasa nearly corresponds with Bronchial asthma. Tamakashwasa in severe condition is life threatening and needs emergency supportive measures. Acharya chakrapani states tamakashwasa can be treated with dhumapana alone without vamana if a condition is arising out of alpadosha. Acharya sushrutha have also explained dhumapana as one of the pradhanakarma as it does kaphapakarshana in tamakashwasa. Shunti Arka is mentioned as one among the shwasaghna arka and it holds the ushna properties to balance vatakapha dosha. Hence nebulization and dhumapana using shunti is useful to manage mild to moderate symptoms of tamakashwasa with certain modification, can be best alternative method for the management of tamakashwasa. |