| CTRI Number |
CTRI/2024/12/078073 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment for Chest Cold |
|
Scientific Title of Study
|
Efficacy of Dhananjaya Vati in the management of Kaphaja Kasa – A randomised controlled clinical trial |
| 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 Yashas M |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of Kayachikitsa
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8088747257 |
| Fax |
|
| Email |
m.yashas97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Susheel Shetty |
| Designation |
Professor and Head |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of Kayachikitsa
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9980431676 |
| Fax |
|
| Email |
shettysusheel13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Susheel Shetty |
| Designation |
Professor and Head |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of Kayachikitsa
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9980431676 |
| Fax |
|
| Email |
shettysusheel13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 2, OPD of Department of Kayachikitsa,
Alvas Ayurveda Medical College and Hospital, Sundari Ananda Alva Campus,
Vidyagiri, Moodubidire,
Dakshina Kannada - 574227,
Karnataka,
India |
|
|
Primary Sponsor
|
| Name |
Dr Yashas M |
| Address |
Department of Kayachikitsa,
Alvas Ayurveda Medical College and Hospital, Sundari Ananda Alva Campus,
Vidyagiri, Moodubidire,
Dakshina Kannada - 574227,
Karnataka,
India |
| 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 Yashas M |
Alvas Ayurveda Medical College and Hospital |
Department of Kayachikitsa,
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire
Dakshina Kannada
KARNATAKA |
8088747257
m.yashas97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Alvas Ayurveda Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J209||Acute bronchitis, unspecified. Ayurveda Condition: KAPAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhananjaya Vati, Reference: Brihat Nighantu Ratnakara, 7th Chapter - Kasakarma Vipaka Adhyaya, Page 237, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: Administered every 2 hours, 6 times a day | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Lavangadi Vati, Reference: Vaidya Jivanam, 3rd Vilasa, 7th Shloka, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: Administered every 2 hours, 6 times a day |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with onset less than 3 weeks
2. Subjects who are ready to give written informed consent.
3. Subjects fulfilling the diagnostic criteria. |
|
| ExclusionCriteria |
| Details |
1. Subjects with other systemic and metabolic diseases
2. Subjects undergoing steroid therapies which may interfere with the course of
treatment
3. Subjects suffering from chronic respiratory conditions
4. Subjects with antibiotic use in the preceding two weeks
5. Pregnant women and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of Kasa with Bahula, Madhura, Snigdha, Ghana Kapha nishteevana
|
Day 0, Day 4, Day 8, Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of TC, DC, ESR, AEC |
Day 0, Day 4, Day 8, Day 15 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="2"
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
|
This study is a randomised, single blind, parallel group, actively controlled comparative clinical study comparing the efficacy of Dhananjaya Vati and Lavangadi Vati with a dosage of two tablets of 250mg each at every 2 hours for 7 days in 60 patients with Kaphaja Kasa that will be conducted at Alvas Ayurveda Medical College and Hospital. The primary outcome measures will be Kasa with Bahula, Madhura, Snigdha, Ghana Kapha nishteevana and Bronchitis Severity Scale at 0, 4, 8 and 15 days. The secondary outcome measures will be TC, DC, ESR and AEC at at 0, 4, 8 and 15 days. |