| CTRI Number |
CTRI/2024/10/075260 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| 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 Vidangadya Churna in the management of Vataj Kasa (Acute Bronchitis). |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Vidangadya Churna in the management of Vataj Kasa (Acute Bronchitis). |
| 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 Girish Vishnu Jadhav |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD NO 13 Kayachikitsa Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
09657709477 |
| Fax |
|
| Email |
girishjadhav285@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Ramrao Nimbalkar |
| Designation |
Associate Professor |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD NO 13 Kayachikitsa Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra. 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9422711098 |
| Fax |
|
| Email |
ayushakti009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girish Vishnu Jadhav |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD NO.13 Kayachikitsa Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
09657709477 |
| Fax |
|
| Email |
girishjadhav285@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 |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi 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 Girish Jadhav |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi |
OPD NO.13 Kayachikitsa department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad
Aurangabad
MAHARASHTRA |
09657709477
girishjadhav285@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: VATAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadya Churna, Reference: Gadanigraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4.5(g), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: Yes(details: -ghrita), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Talisadi Churna, Reference: Sharangdhar madhyam khanda, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) patients of age group 20 to 45 years.
2) patients irrespective of Gender,Religion,Profession,Martial status and socioeconomic status.
3)patients showing classical lakshanas of vataj kasa that mentioned in samhita. |
|
| ExclusionCriteria |
| Details |
1) patient with other severe systemic disorder and also sign and symptoms other than vataj kasa.
2) patient with known respiratory disorder like Tuberculosis,COPD,Asthma,CA lungs.
3) pregnant and lactating mothers.
4) patient below age group 20 years and above 45 years will be excluded. |
|
|
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 |
| Shushka Kasa (Dry Cough), parshwa shoola (lateral side chest pain ), Uraha Shoola(chest pain) this lakshanas will be decrease |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| shiraha shoola, Daurbalya(General weakness) this lakshanas will be decrease |
14 days |
|
|
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)
|
22/10/2024 |
| 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
|
The prana and udana vayu are responsible for normal functioning of praanvaha srotas, which can be altered due to causative factors in turn lead to manifestation of kasa. vataj kasa which is characterized by these lakshanas shushka gala, shushkakasa with shushka-alpakapha , swarbheda, parshvashoola, shirahashoola, urahashoola, dourbalya. vataj kasa is caused by intake of ununctous (dry), cold and kashaya(astringent) food items. intake of less food or not consuming food at all i.e pramita and anasana . supresssion of natural urges and excessive physical strain.
Acute bronchitis can be caused by allergens, irritants and bacteria. irritants include smoke inhalation, dust, among others. acute bronchitis shows symptoms like dry cough, sore throat, headache, chest soreness which are similar to vataj kasa. so, vataj kasa is taken with special reference to acute bronchitis.
Study will be conducted on 92 diagnosed patients of Vataj Kasa. written consent will be taken. intial assessment will be done. patient will be treated with interventional group Vidangadya churna and Control group Talisadi churna. patient will be assessed at follow up. observation and result will be note and statistical analysis, Discussion and Conclusion will be done.
Null hypothesis (Ho)- Vidangadya churna is not effective in the management of Vataj Kasa (Acute bronchitis).
Alternate hypothesis (H1)- Vidangadya churna is effective in the management of Vataj kasa (Acute bronchitis). |