| CTRI Number |
CTRI/2021/08/035798 [Registered on: 19/08/2021] Trial Registered Prospectively |
| Last Modified On: |
13/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Two Ayurvediya drugs] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF DURALABHADI LEHA(AN AYURVEDIC
MEDICINE ) AND INDRAVARUNIKADI CHURNA (AN
AYURVEDIC MEDICINE) IN ASTHMA. |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY OF DURALABHADI LEHA AND
INDRAVARUNIKADI CHURNA IN THE MANAGEMENT OF TAMAK SHWASA WITH
SPECIAL REFERENCE TO PRINCIPLE तमके तॠविरेचनम(च.चि. 17/121) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushil Kumar Kaswan |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda(Deemed to be university) |
| Address |
P.G.Dept. of Samhita and Maulik Sidhhanta National Institute of Ayurveda Jaipur
P.G.Dept. of Samhita and Maulik Sidhhanta National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8290754544 |
| Fax |
|
| Email |
skkaswankishu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Nisha Gupta |
| Designation |
professor h.o.d. of samhita dept. |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G.Dept. of Samhita and Maulik Sidhhanta National Institute of Ayurveda Jaipur
P.G.Dept. of Samhita and Maulik Sidhhanta National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9828087640 |
| Fax |
|
| Email |
guptadr.nisha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sushil Kumar Kaswan |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G.Dept. of samhita and maulik sidhhanta national institute of ayurveda jaipur
P.G.Dept. of samhita and maulik sidhhanta national institute of ayurveda jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8290754544 |
| Fax |
|
| Email |
skkaswankishu@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(raj) |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sushil Kumar Kaswan |
National Institute of Ayurveda (Deemed to be university) |
OPD Number 7 and 21 of Dept. of samhita and maulik siddhanta NIA Madhav vilas palace Amer road Jaipur(raj) pin code-302002
Jaipur
RAJASTHAN |
8290754544
skkaswankishu@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:J453||Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Indravarunikadi Churna, Reference: Bh.R. 16, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Duralabhadi leha, Reference: Su. U. 51/33, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Ages ranging from 18 years to 60 years.
Those ready to give written informed consent.
Patient present with sign and symptom of Tamak shwasa.
Eligible patient able to participate for 8 weeks. |
|
| ExclusionCriteria |
| Details |
Patients with severe bronchial asthma. Patients present with associated morbid disorder.(TB etc.)
Patient with poorly controlled hypertension (i.e. systolic >160 mm of HG and diastolic >100
mm of HG)
Pregnancy or lactating women.
Patients with alcohol dependence.
H/o Hypersensitivity to the trial drugs or any of its ingredients.
Patient with evidence of malignancy. Symptomatic patient with clinical evidence of heart failure. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the clinical symptoms ofTamak shwasa. 1.Shwasakrichhta (Dyspnoea)
2.Peenasa ( Nasal discharge)
3.Kasa (Cough)
4.Kapha nishatheevana (Expectoration)
5.Ghurghurakam shabda (Wheezing)
6.Urahshoola (Chest pain) |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in the laboratory parameters.
2. Frequency |
60 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)
|
30/08/2021 |
| 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="0"
Months="10"
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
|
Need of the study- Modern science manages Tamak Shwasa (Bronchial Asthma) by administration of bronchodilators and corticosteroids with long acting beta agonist. Which have serious adverse effects like nausea, vomiting, tremors and huskiness of voice and have limitation for a high time therapy due to drug dose dependency. It is required to find out a potential remedy for Tamak Shwasa (Bronchial Asthma) which is easily compatible with the human body. There is a need to find out a treatment which is safer, effective, non-toxic and cheaper. Such remedies could be explored from the huge wealth of Ayurveda. Aims and objective of the study- To compare the efficacy of ’Duralabhadi leha’ alone and ’Indravarunikadi churna’ alone in the management of the Tamak shwasa. Hypothesis- ’Duralabhadi leha ’ is more effective than ’Indravarunikadi churna ’in the management of Tamak shwasa. Null hypothesis-- There is no difference between the efficacy of ’Indravarunikadi churna’ and ’Duralabhadi leha’ in the management of Tamak shwasa. Alternate hypothesis- ’ Indravarunikadi churna’ is more effective than ’Duralabhadi leha’ in the management of Tamak shwasa. Lab investigations- 1. ESR, CBC. 2. Spirometry. |