| CTRI Number |
CTRI/2021/04/033056 [Registered on: 23/04/2021] Trial Registered Prospectively |
| Last Modified On: |
22/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF ‘SAPTAMRITA VATI’ AND ‘VIRECHANA
KARMA’ IN TAMAKA SHWASA WITH SPECIAL REFERENCE TO BRONCHIAL ASTHMA
|
|
Scientific Title of Study
|
CLINICAL EVALUATION OF ‘SAPTAMRITA VATI’ AND ‘VIRECHANA
KARMA’ IN THE MANAGEMENT OF TAMAKA SHWASA W.S.R. TO BRONCHIAL ASTHMA
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Agrawal |
| Designation |
Pg Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
P.G. Dept. of Kayachikitsa National Institute of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8349307983 |
| Fax |
|
| Email |
drdivyaagrawal112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ram Kishor Joshi |
| Designation |
Head of Department |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
P.G. Dept. of Kayachikitsa National Institute of Ayurveda Jaipur RAJASTHAN
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414322297 |
| Fax |
|
| Email |
joshirk1964@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Upadhyay |
| Designation |
Lecturer |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
P.G. Dept. of Kayachikitsa National Institute of Ayurveda Jaipur RAJASTHAN
Jaipur
RAJASTHAN
302002
India |
| Phone |
9915613039 |
| Fax |
|
| Email |
dr.abhishek82@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Madhav Vilas Palace Amer Road Jaipur Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Madhav Vilas Palace Amer Road Jaipur Rajasthan- 302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR DIVYA AGRAWAL |
National Institute Of Ayurveda Jaipur |
OPD NO- 1,7,18,22,25 Dept. pf Kayachikitsa Madhav Vilas Palace Amer Road Jaipur 302002 Jaipur Rajasthan
Jaipur
RAJASTHAN |
8349307983
drdivyaagrawal112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee national institute of ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
saptamrita vati |
15 patients will be administered saptamrita vati in dose of 5 grams twice a day empty stomach orally for 30 days |
| Comparator Agent |
virechana karma |
15 patients will be administered virechana karma after snehan and swedan and virechana will be given with Abhayadi modaka 2 tablets empty stomach orally on 3rd day after stoping snehapan. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing for trial and give consent.
2. Patients of age group 18 to 70 yrs of either sex.
3. Patients having signs and symptoms of Tamak Shwasa i.e., Shwasakrucchata, Kasa (cough), Pratishyaya (chronic rhinitis), Bhasankrucchata (difficulty in speech), Nidralpata (inadequate sleep), Ghurghuraka (audible sounds)
4. Patients fit for Virechana Karma.
5. Patients who is not taking any allopathic medication for Asthma.
6. Mild & moderate cases of Bronchial Asthma
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing for trial.
2. Age below 18 years and above 70 years of age of either sex.
3. Patients suffering from Pulmonary tuberculosis, Cardiac Asthma, Bronchogenic carcinoma, Chronic obstructive Productive disease, Pleural effusion
4. Status Asthmaticus
5. Patients suffering from serious heart diseases or any other serious health aliment.
6. Patient with rectal or vaginal prolapse
7. Pregnant and lactating women
8. Patients, who are unfit for Virechana Karma
9 Patients, who is taking any allopathic medication for Asthma
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical Symptoms of Tamaka Shwasa |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes in Asthma control questionnaire
2. Changes in Spirometry- FVC1% and PEFR
3. Changes in MRC Dyospnea Scale.
|
30 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/05/2021 |
| 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
|
Disease reference- Agnivesha, Charakasamhita, ChikitsaSthana, Hikkashwasa Chikitsa
Adhyaya, Drug reference- 1. Ras
Ratna Sammuchaya, Hikka Shwasa Chikitsa prakran 13/56,57,58,59 ) 2. virechana
karma reference- ,
Hikkashwasa Chikitsa Adhyaya, 17/21, 3. ibidem, Charakasamhita, Panchkarameeya
Siddhi Adhayya 2/11, pg. no. 688 4. ibidem, Ashtanga Hridaya, Doshoparkramaneeya
Adhayaya 13/29,pg.no. 217 5.
ibidem, Charakasamhita, Siddhisthana, Kalpana Siddhi
Adhayya 1/6, pg. no. 677 ch.su 16/7-8. NEED OF STUDY:
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 chronic obstruction pulmonary
disease will become the third leading cause of death8. With an
estimated 1.5-2 crores asthma patients, at least one in every 10 asthma patient
globally lives in India. Globally, the economic costs associated with asthma
exceed those of TB and HIV/AIDS combined. Asthma is prevalent in all countries,
whether they are developed or underdeveloped. In fact, over 80 percent of
asthma deaths according to the World Health Organization (WHO), occur in low
and lower-middle-income countries9.
Line of treatment adopted in Bronchial Asthma includes the use of inhaler of
corticosteroids, leukotriene receptor antagonist, methylxanthines
etc. After taking modern drugs patient quality of life still remains
compromised10.
As per Ayurvedic classics main line of treatment for Tamaka Shwasa include
both Shodhana and Shamana Chikitsa, Acharya
Charak has described the Shodhana procedure as
“ तमके तॠविरेचनमॠ“ 11 In Shamana Chikitsa the food or drug which is
Vata Karaka and Kapha Nashaka or Kapha
Karaka and Vata Shamaka is indicated and in single
arm treatment only Vata Shamaka or Kapha Shamaka Chikitsa is
indicated.12 Variety of treatment modalities including Shamana
and Shodhana have been described in Ayurveda for
management of Shwasa Roga. Considering these factors this study has
been planned to evaluate the efficacy of Virechana Karma and Saptamrita
Vati in Tamaka Shwasa. HYPOTHESIS: Null Hypothesis [H0] Saptamrita Vati and Virechana Karma are
equally effective in Tamaka Shwasa (Bronchial
Asthma). Alternate Hypothesis[H1] Saptamrita Vati and Virechana Karma are
not equally effective in Tamaka Shwasa (Bronchial Asthma)
FOLLOW UP- 0,15th and 30th day.
|