| CTRI Number |
CTRI/2022/03/041521 [Registered on: 31/03/2022] Trial Registered Prospectively |
| Last Modified On: |
29/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of Ashwagandha Kshaar on cough in children. |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Ashwagandha Kshaar on Kaphaj kasa in pediatric age group. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lalit Mohan Bhatt |
| Designation |
PG Scholar |
| Affiliation |
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C. G.) |
| Address |
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C. G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9690363169 |
| Fax |
|
| Email |
dr.lalit.ayurveda12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lowkesh Chandravanshi |
| Designation |
Lecturer |
| Affiliation |
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C. G.) |
| Address |
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C. G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827822231 |
| Fax |
|
| Email |
lowkeshc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyawati Rathia |
| Designation |
Lecturer |
| Affiliation |
Shri Narayan Prashad Awasthi Govt. Ayurveda College |
| Address |
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C. G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9924975823 |
| Fax |
|
| Email |
satirathiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur C G 492010 |
|
|
Primary Sponsor
|
| Name |
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur C G |
| Address |
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C. G.) 492010 |
| Type of Sponsor |
Government 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 Lalit Mohan Bhatt |
Shri khudadad Doongaji Government Ayurved Hospital |
Department of
Kaumarabhritya OPD No 7 and IPD
patient Shri khudadad
Doongaji Government
Ayurved Hospital
Raipur Chhattisgarh
492010
Raipur
CHHATTISGARH
Raipur
CHHATTISGARH |
9690363169
dr.lalit.ayurveda12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF THE PRINCIPAL ,SHRI NARAYAN PRASAD AWASTHI GOVERMENT AYURVED COLLEGE RAIPUR CHHATTISGARH 492010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J06||Acute upper respiratory infections. Ayurveda Condition: Kaphaj kasa, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ASHWAGANDHA KSHAAR, Reference: CHARAK SAMHITA CHIKITSASTHAN CHAPTER 17/117-119, Route: Oral, Dosage Form: Kshara , Dose: 87(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 20 Days, anupAna/sahapAna: Yes(details: -MADHU AND GHRITA IN RATIO 3:1), Additional Information: -Doses will be calculated according to Body Surface Area. The dose range is 87 mg to 295mg |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group 5-15 years.
2.Sex- both male and female.
3.Patient with symptoms of Kaphaj Kasa.
4.Patient with feeling of tiredness, body ache along with wheezing, shortness of breath.
5.Subject willing to participate in study after signing consent.
|
|
| ExclusionCriteria |
| Details |
1.Children below 5 years and above 15 years.
2.Kaphaj Kasa as a symptom of other disease.
3.Chronic disorders like Tuberculosis, Heart Disease, COPD [Chronic Obstructive Pulmonary Disease], Pulmonary abscess, Carcinoma, Pleural effusion, Pneumothorax, Status asthmatics, Congenital and genetic malformations.
4.Patient on long term medication (Steroids, etc)
5.Patient tested positive for Covid-19.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Kasa vega(Frequency of cough) reduced
2.Nisthavati Ghanam Kapham (Productive cough) reduced |
At baseline, 10th day and then every 15 day for the period of 2 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Vaksha Sampurnamiv manyate [Feeling of mucus in chest region] relived
2. Kanthoplepa [Feeling of mucus coating in upper respiratory tract ] relived
3.Aruchi [Anorexia] relieved
4.Pinasa [Rhinitis] relieved |
20 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/04/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Physiologically Kapha dosha is predominant in balya-awastha, may cause various Kaphaj vyadhi such as Kphaj kasa. This is one of the most common disease that affect Pranvah shrotas and further health of the child. Acharya Charak has prescribed Ashwagandha kshaar in the management of Kapha avrudha marga Kasa. Present study is aimed to re-evaluate the effect of Ashwagandha Kshaar on Kaphaj Kasa (Productive cough). In this study subject will be advised for oral administration of Ashwagandha kshaar and dose of administration will be calculated based on Body Surface Area. Ashwagandha kshaar will be advised in viscous liquid form with unequal amount of Madhu and Ghrita (ratio 3:1) for 20 days and follow-up will be done on every 10 days. Post treatment follow ups will be done in every 15 days for 2 months. Assessment will be done on the basis of subjective and objective criteria adopted for this study. |