| CTRI Number |
CTRI/2025/02/081085 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Agastya Haritaki Rasayana and Gudardraka in the Management of Kaphaja
Kasa (Wet Cough) in Children |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the
Efficacy of Agastya Haritaki Rasayana and Gudardraka in the Management of Kaphaja
Kasa (Wet Cough) in Children: An Open-Label Randomized Controlled Study |
| 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 Swati Sharma |
| Designation |
PhD scholar |
| Affiliation |
Institute of Ayurved Studies ands Research, Shri Krishna Ayush university , Kurukshetra , Haryana |
| Address |
Room no 99 Pg department of Kaumarbhritya Institute of Ayurvedic
studies and researchShri Krishna AYUSH university Kurukshetra
Haryana
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
7318324555 |
| Fax |
|
| Email |
drswatisharma2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Shambhu dayal Sharma |
| Designation |
Professor, P.G. Department of Kaumarbhritya |
| Affiliation |
Institute of Ayurved Studies ands Research, Shri Krishna Ayush university , Kurukshetra , Haryana |
| Address |
Room no 99 Pg department of Kaumarbhritya Institute of Ayurvedic
studies and researchShri Krishna AYUSH university Kurukshetra
Haryana
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
7988688231 |
| Fax |
|
| Email |
sharmasddr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Shambhu dayal Sharma |
| Designation |
Professor, P.G. Department of Kaumarbhritya |
| Affiliation |
Institute of Ayurved Studies ands Research, Shri Krishna Ayush university , Kurukshetra , Haryana |
| Address |
Room no 99 Pg department of Kaumarbhritya Institute of Ayurvedic
studies and researchShri Krishna AYUSH university Kurukshetra
Haryana
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
7988688231 |
| Fax |
|
| Email |
sharmasddr@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Ayurveda studies and Research,Shri Krishna AYUSH university, Kurukshetra ,
Haryana. |
|
|
Primary Sponsor
|
| Name |
Institute of Ayurveda studies and Research,Shri Krishna AYUSH university, Kurukshetra , Haryana |
| Address |
Room no 99 Pg department of Kaumarbhritya, Institute of Ayurveda
studies and research,Shri Krishna Ayush university, Kurukshetra ,
Haryana. |
| 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 Bharti |
Central Ayurveda Research Institute, New delhi |
Dhanvantari bhavan, Director,s chamber, Road no 66, Punjabi baag west, New Delhi pin code-110026
West
DELHI |
9868109737
drbhartidelhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Cebntral Ayurveda Research Institute, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J22||Unspecified acute lower respiratory infection. Ayurveda Condition: KAPAJAKASAH, (2) ICD-10 Condition:J22||Unspecified acute lower respiratory infection. Ayurveda Condition: KAPAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: AGASTYAHARITAKIRASAYANA, Reference: Astangahridya, Chiktsasthana, Adhyaya 3:125-130 1/2), API, part- 1,second edition, page 108, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 20 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: NA | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: GUDARDRAKA, Reference: Sahasrayoga, lehyaprakrana, page285, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 20 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of aged between 8 to 12 years, irrespective of gender, religion and socio economical
status.
2. Children presenting with clinical features (one or more) of Kaphaja Kasa lesser than 14days
e.g. Snigdha (Unctuous), Ghana(Solid), Bahal Kaphasthivana (Cough with expectorant) other
features associated with Peenasa (Nasal discharge), Chardi (Vomiting), Alparuk in Uras (Mild
chest pain), Kanthaupalepa (Coating in the throat), Mandagni (Reduced appetite), and
Sampoornavakshas (Fullness in the chest).
3. Parents/guardians willing to provide a written informed consent form for the participation
of their children.
|
|
| ExclusionCriteria |
| Details |
1.Children suffering from any chronic illness of any other system.
2. Any type of Cough with chronicity of more than or equal to 14days.
3.Children with congenital anomalies and diagnosed case of asthma, pulmonary tuberculosis,
COPD and chronic debilitating illnesses.
4.Children with neurological and hereditary diseases.
5. Any other condition that the Investigator thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome measure will change in the clinical symptoms
grading of Kaphaj Kasa.
|
35 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Change in Leicester cough Questionnaire to evaluate the impact of cough on quality of life.
b. Change in values of laboratory parameters. CBC, KFT ,LFT to assesses safety of drug.
c. PEFR to assess ventilation adequacy
c. Assessment of the safety of the drug by documenting the occurrence of any adverse drug reactions
(ADR)/adverse events (AE) during the course of the study. |
35 days |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
01/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Through appropriate request
- For how long will this data be available start date provided 31-03-2026 and end date provided 30-03-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
In Ayurveda Kasa (Cough) is explained under Pranavaha Srotovikara. Kaphaja Kasa is a one type of Kasa Roga and is characterized by Snigdha (Unctuous), Ghana(Solid), Sandra Kaphasthivana (Cough with expectorant) other features associated with Peenasa (Nasal discharge), Chardi (Vomiting), Alparuk in Uras (Mild chest pain), Sthaimitya (Heaviness in the chest), Kanthaupalepa(Coating in the throat), Mandagni (Reduced appetite), Aruchi (Anorexia) and Sampoornavakshas (Fullness in the chest)etc. Children naturally having Kaphadosha predominant and indulging of Kaphakara Ahara and Vihara, produces more incident of KaphajaKasa.
Global Challenge: Cough is one of the most common complaints prompting patient visits to health care professionals, especially in paediatric clinic. Cough is the 5th common complaint for which patients seek care and prevalence rate of which is 25% in children worldwide. Two thirds of children, visit their doctors at least once a year with acute respiratory infections, and up to three-quarters of them will have a cough which sounds wet.
Allopathic Medication for Cough: Treatment for wet cough in allopathy mainly comprises of Antibiotics, Antitussive, and other symptomatic treatment. In the majority of cases of wet cough lesser than 14 days are caused by viral, upper respiratory tract infections which do not warrant specific treatment or lesser treatment. Owing to the similarity in the etiology and symptoms, the management of Kaphaja Kasa holds good for wet cough. Here Ayurveda may prove as harmless natural management in Kaphaja Kasa (wet cough) of chronicity lesser than 14 days.
Ayurvedic Treatment Approach: Ayurveda proposes a comprehensive management guideline for Kasa that include drugs and formulations. Deepana, Strotoshodhana, Katu, Ruksha, Ushna, Kaphaghna treatment forms the basis principles of Kaphaja Kasa (wet cough).
Study Drugs:
AGASTYA HARITAKI RASAYANA : Drug Reference is from classical Ayurveda text Astangahridya, Chiktsasthana, Adhyaya 3:125-130 1/2) and API, part- 1,second edition, page 108.
GUDARDRAKA: Drug Reference is from classical Ayurveda text Sahasrayoga, lehyaprakrana, page285. Both the formulations are in Avleha form with natural ingredients, which is palatable to children.
Study Objectives:
Primary:
1. To compare the efficacy of Gudardraka and AgastyaHaritaki Rasayana on the clinical features of Kaphaj Kasa in Children.
Secondary:
1. To study the efficacy of Gudardraka and Agastya Haritaki Rasayana in the improvement of quality of life.
2. To study the safety of Gudardraka and Agastya Haritaki Rasayana in the management of Kaphaj Kasa in Children.
Primary outcome measures :
a. The primary outcome measure will change in the clinical symptoms grading of Kaphaj Kasa.
Secondary outcome measures:
a. Change in Leicester cough Questionnaire to evaluate the impact of cough on quality of life.
b. Change in values of laboratory parameters. CBC, KFT ,LFT to assesses safety of drug.
c. PEFR to assess ventilation adequacy
c. Assessment of the safety of the drug by documenting the occurrence of any adverse drug reactions (ADR)/adverse events (AE) during the course of the study.
Significance: Offers a Ayurveda management childhood wet cough without harmful side effects.
|