| CTRI Number |
CTRI/2024/10/075544 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the efficacy of Nagaradi Churna in the management of Tamakashwasa Avegavashta (Bronchial Asthma) |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Nagaradi Churna in the management of Tamakashwasa Avegavashta (Bronchial Ashtma) |
| 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 Sanobar Shakil Mulani |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S. ayurved mahavidyalaya and rugnalaya kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD NO. 13 kayachikista department C.S.M.S.S. ayurved mahavidyalaya and rugnalaya,Kanchanwadi,Paithan road, Aurangabad, Maharashtra, India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7218675986 |
| Fax |
|
| Email |
sanobar231097@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashashri Arun Vitonde |
| Designation |
Associate Professor |
| Affiliation |
C.S.M.S.S AYURVED MAHAVIDYALAYA AND RUGNALAYA KANCHANWADI AURANGABAD MAHARASHTRA INDIA 431011 |
| Address |
OPD NO. 13 Kayachikista Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya , Kanchanwadi , Paithan Road , Aurangabad , Maharashtra, India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9423649578 |
| Fax |
|
| Email |
yashashri15aug@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanobar Shakil Mulani |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S. ayurved mahavidyalaya and rugnalaya kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD NO. 13 kayachikista department C.S.M.S.S. ayurved mahavidyalaya and rugnalaya Kanchanwadi , Paithan road Aurangabad, Maharashtra, India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7218675986 |
| Fax |
|
| Email |
sanobar231097@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
|
|
Primary Sponsor
|
| Name |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD NO.13 Kayachikista department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Aurangabad Maharashtra India 431011 |
| Type of Sponsor |
Private medical college |
|
|
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 Sanobar Shakil Mulani |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431011 |
OPD NO.13 Kayachikista Department C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Aurangabad Maharashtra India 431011
Aurangabad
MAHARASHTRA |
7218675986
sanobar231097@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC C.S.M.S.S ayurved mahavidya and rugnalaya Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, (2) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: TAMAKASVASAH, (3) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH, (4) 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: Talisadi Churna, Reference: Charak Samhita Chikistasthana Adhyaya Number 8 Shloka Number 146 and 147, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -No | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nagaradi Churna, Reference: Bharat Bhaishajya Ratnakar Tritiya Bhaga Shloka Number 3422, Route: Oral, Dosage Form: Churna/ Powder, Dose: 03(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -No |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having sign and symptoms of Tamakashwasa mentioned in ayurvedic samhitas will be selected such as Shwasakrichhrata (Breathlessness), Kasa (Cough), Ghurghurkam Dhwani (wheezing), Kaphasthivana Krichhrata (Difficulty in expectoration), Peenasa(Coryza). |
|
| ExclusionCriteria |
| Details |
1) Patients of ARDS, COPD, TB, CA lung.
2) Patients having comorbidity like HTN, DM, AIDS or other systemic and endocrine diseases.
3) Patients having psychological and neurological disorders.
4) Steroid dependent patients more than 1year.
5) Pregnant and lactating women.
6) Patient age less than 20 years and more than 40 years |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kasa (Cough), Peenasa( Coryza),
Ghurghurkam Dhwani (Wheezing) this lakshanas will be decreased. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shwasakricchrata (Breathlessness) , Kaphashtivana kricchrata (Difficulty in expectoration) this lakshanas will be decreased. |
21days |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
04/11/2024 |
| 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="6"
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
|
There are 5 types of vata doshas out of which prana and udana vayu contribute to the process of respiration through pranavaha strotasa . The normal function of respiration through pranavaha strotasa, The normal fuunction of respiration is a sign of healthy life. The defect in pranavayu and udanavayu causes so many respiratory diseases out of which one is Tamakashwasa. The term Tamakashwasa is composed of two words 1)Tamak is derived from Tamas which means Andhakar that is darkness , 2) Shwasa is derived from Shwas which means Jivane which means living or life. Vayu moving in pratiloma that is reverse order pervades the channel (of pranavaha) afflicts the head and the neck and stimulates phlegm to cause Peenasa (Coryza) . This obstructed vayus produces signs and symptoms like ghurghurkam dhwani (wheezing and murmur sounds) and dyspnea of exceedingly deep velocity which is immensely injurious to life. Patient get relief from symptoms soon after sputum expelled, develops special liking for hot things, eyeballs becomes projected outside. Rationale- 1) The sedentery lifestyle environmental changes are the aggrevating factors in the bronchial asthma 2) Global ,regional and national prevalence of bronchial asthma has been found around 8.8% 3) In modern medicines bronchodilators , corticosteroids and inhalers are used in treatment which are having measure side effects. So with ayurvedic dinacharya , rutucharya , pathya apathya kalpana can treat the disease and reduce prevalencde and complications of asthma. 4) The ingredients used in Nagaradi churna are easily available and are cost effective with very minimal or no adverse drug effect.
Hypothesis- A) Null Hypothesis- Nagaradi Churna is not effective in the management of Tamakashwasa-Avegavastha (Bronchial Asthma) B) Alternative Hypothesis- Nagaradi Churna is effective in the management of Tamakshwasa-Avegavastha (Bronchial Asthma)
The study will be conducted on 92 patients with 46 patients of trial group will be treated with Nagaradi Churna and the other 46 patients of Control group will be treated with Talisadi Churna and the result will be conducted. |