| CTRI Number |
CTRI/2022/06/043421 [Registered on: 22/06/2022] Trial Registered Prospectively |
| Last Modified On: |
20/06/2022 |
| 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
|
Ayurvedic Management of Pulmonary Eosinophilia- A Clinical Study |
|
Scientific Title of Study
|
A Randomized Open Label Controlled Clinical Study To Evaluate The Efficacy Of Vyaghriharitaki Avaleha In The Management Of Vataja Kasa With Special Reference To Pulmonary Eosinophilia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjushri P |
| Designation |
Pg Scholar |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research |
| Address |
Room Number 304 Department Of Pg Studies In Kayachikitsa Sri Sri College Of Ayurvedic Science And Research 21st Km Kanakapura Road Udayapura Post Bangalore
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
7975851807 |
| Fax |
|
| Email |
manjup.02.95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopalakrishna G |
| Designation |
Professor and Head Of The Department |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research |
| Address |
Room Number 304 Department Of Pg Studies In Kayachikitsa Sri Sri College Of Ayurvedic Science And Research 21st Km Kanakapura Road Udayapura Post Bangalore
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9448173128 |
| Fax |
|
| Email |
Lakshmimp1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjushri P |
| Designation |
Pg Scholar |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research |
| Address |
Room Number 304 Department Of Pg Studies In Kayachikitsa Sri Sri College Of Ayurvedic Science And Research 21st Km Kanakapura Road Udayapura Post Bangalore
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
7975851807 |
| Fax |
|
| Email |
manjup.02.95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College Of Ayurvedic Science And Research Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Manjushri P |
| Address |
Pg Scholar Room Number 304 Department Of Pg Studies In Kayachikitsa Sri Sri College Of Ayurvedic Science And Research 21st Km Kanakapura Road Udayapura Post Bangalore |
| 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 Manjushri P |
Sri Sri College Of Ayurvedic Science And Research Hospital |
Room Number 5 Department Of Kayachikitsa Sri Sri College Of Ayurvedic Science And Research Hospital 21st Km Kanakapura Road Udayapura Post Banglore
Bangalore Rural
KARNATAKA |
7975851807
manjup.02.95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J82||Pulmonary eosinophilia, not elsewhere classified. Ayurveda Condition: EA-3.2 MORBIDITY CODE FOR VATAJA KASA, (2) ICD-10 Condition: J82||Pulmonary eosinophilia, not elsewhere classified, (3) ICD-10 Condition: J82||Pulmonary eosinophilia, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vyaghriharitaki Avaleha, Reference: Bhaishajya Kalpana, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Hot Water), Additional Information: -VYAGHRIHARITAKI AVALEHA IS A POLYHERBAL FORMULATION CONTAINING 11 INGREDIENTS NAMELY KANTAKARI HARITAKI SHUNTI MARICHA PIPPALI TVAK TEJAPATRA ELA NAGAKESHARA MADHU GUDA | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidangadi Churna, Reference: Charaka Chikitsa 17, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Hot Water), Additional Information: VIDANGADI CHURNA IS A POLYHERBAL FORMULATION CONTAING 8 INGREDIENTS NAMELY VIDANGA PIPPALI NAGARA RASNA BHARANGI SAINDHAVA YAVAKSHARA HINGU |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects Having Shushka Kasa With Three Or More Classical Signs And Symptoms Of Vataja Kasa With Special Reference To Pulmonary Eosinophilia
2 Absolute Eosinophilic Count From 500 Cells Per Cu mm to 2500 Cells Per Cu mm
3 Subjects Willing To Participate With Written Informed Consent
|
|
| ExclusionCriteria |
| Details |
1 Subjects Diagnosed With Other Respiratory Diseases Like Pulmonary Tuberculosis Bronchial Asthma Pneumonia Pleurisy Ca Bronchus Emphysema And Complicated Covid-19 Cases
2 Uncontrolled Systemic Illness Like Diabetes Mellitus Type1 Type 2 And Hypertension
3 Pregnant And Lactating Women
4 Any Other Systemic Illness Interfering The Course Of Treatment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction In Signs And Symptoms Of Vataja Kasa like Shushka Kasa Prasakta Vega Shirashoola Parshwa Shoola Hrit Shoola Swara Bheda Kshamanana
|
15th Day during the Trial Period
30th Day Post Trial Period
45th Day After Follow up Period of Trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction In Levels Of Absolute Eosinophilic Count |
30th Day 45th Day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
27/06/2022 |
| 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
|
THIS CLINICAL TRIAL IS PUT FORWARD TO EVALUATE THE EFFICACY OF VYAGHRIHARITAKI AVALEHA IN THE MANAGEMENT OF VATAJA KASA WITH SPECIAL REFERENCE TO PULMONARY EOSINOPHILIA
HYPOTHESIS
1 NULL HYPOTHESIS
H0: THE EFFICACY OF VYAGHRIHARITAKI AVALEHA IS EQUIVALENT TO VIDANGADI CHURNA IN THE MANAGEMENT OF VATAJA KASA WITH SPECIAL REFERENCE TO PULMONARY EOSINOPHILIA
2 ALTERNATIVE HYPOTHESIS
H1: THE EFFICACY OF VYAGHRIHARITAKI AVALEHA IS DIFFERENT THAN VIDANGADI CHURNA IN THE MANAGEMENT OF VATAJA KASA WITH SPECIAL REFERENCE TO PULMONARY EOSINOPHILIA |