| CTRI Number |
CTRI/2025/12/098893 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study to assess the efficacy of Drakshadi Churna and Talishadi Churna in the management of Kasa w.s.r. to recurrent Upper Respiratory Tract infection of viral origin in children. |
|
Scientific Title of Study
|
A randomized, double blind, parallel group study comparing the efficacy of Drakshadi Churna and Talishadi Churna in the management of Kasa w.s.r. to recurrent Upper Respiratory Tract infection of viral origin in children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naveen Kumar |
| Designation |
Pg scholar |
| Affiliation |
Government Ayurvedic College , Kadamkuan |
| Address |
Dpt. of Kaumarbharitya, Government Ayurvedic College and Hospital, Patna,Bihar-800003.
Patna
BIHAR
800003
India |
| Phone |
7256807588 |
| Fax |
|
| Email |
naveen.k28111996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Chaurasia |
| Designation |
Professor & HOD Department of Kaumarbhritya, Government Ayurvedic College, Patna |
| Affiliation |
Government Ayurvedic College , Kadamkuan |
| Address |
Department of Kaumarbhritya, Government Ayurvedic College and Hospital, Patna,Bihar-800003.
Patna
BIHAR
800003
India |
| Phone |
9835255180 |
| Fax |
|
| Email |
arvindschaurasia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Chaurasia |
| Designation |
Professor & HOD Department of Kaumarbhritya, Government Ayurvedic College, Patna |
| Affiliation |
Government Ayurvedic College , Kadamkuan |
| Address |
Department of kaumarbhritya,Government Ayurvedic College and Hospital, Patna,Bihar-800003.
Patna
BIHAR
800003
India |
| Phone |
9835255180 |
| Fax |
|
| Email |
arvindschaurasia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Patna,Bihar-800003. |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital, Patna |
| Address |
Government Ayurvedic college and hospital,Near Buddh Murti,Kadamkuan, Patna, Bihar-800003 |
| 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 Naveen Kumar |
Dpt of Kaumarbhritya, Government Ayurvedic College and Hospital |
Landmark- Buddha Murti, Kadamkuan, Patna,Bihar-800003.
Patna
BIHAR |
7256807588
naveen.k28111996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J399||Disease of upper respiratory tract, unspecified. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: DRAKSHADI CHURNA, Reference: YOGRATNAKAR, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -MADHU), Additional Information: -FOLLOW UP ON TIMELY(2) Medicine Name: TALISHADI CHURNA, Reference: CHARAK SAMHITA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -MADHU), Additional Information: -FOLLOW UP ON TIMELY |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of age group of 2 years to 12 years Simple cough associated with Tonsillitis, Pharyngitis, Sinusitis will also be included those who have recurrent cough lasting more than 8 weeks. |
|
| ExclusionCriteria |
| Details |
Cough with other systems involved Pulmonary tuberculosis, COPD, Bronchiectasis & Tropical eosinophilia or with any other systemic disorders Acute or severe exacerbation & status asthmaticus that require immediate intervention Presence of exudates/pus point on pharynx with enlarged tender cervical nodes and absence of nasal discharge 12. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the signs and symptoms of kasa |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to access the efficacy of trail medicine on kasa |
30 day |
|
|
Target Sample Size
|
Total Sample Size="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="0"
Months="9"
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
|
Ensuring a healthy childhood is crucial for laying the groundwork for a fulfilling adult life. Childhood serves as the cornerstone upon which adulthood is built. Some illnesses might not pose a threat to life but can significantly disrupt daily activities, causing annoyance and irritation. One such common ailment is cough, which has become more widespread in recent times. More over when neglected they may lead to a series of complications later. A very common clinical condition, Kasa (Cough) is one among them increasingly prevalent now a days, demanding greater concern over it. Cough is the fifth most common symptom for which patients seek care. Prevalence of Kasa in children is as 34% - 55% and is one of among top ten causes to visit OPD.Cough occurs in asscciation with acute upper respiratory infection, acute pharyngitis, acute bronchitis and chronic sinusitis, all of which rank among the top 10 reasons for visiting family physicians. The leading cause of recurrent attack of cough in children throughout the world is increased environmental exposure. According to nation health portal of India contributes to 18% of total global population with acute respiratory infection as one of the prominent causes of mortality in children >5 years of age. Childhood being the Kapha predominate age children are more often to suffer with various Pranavaha Srotas Vikara. Kasa is one such condition mentioned in our classic for which our literature has numerous effective formulations. Even though specific antibiotics, antitussive, expectorants are being used in the contemporary science has only been able to give short period of remission and prolonged use has been found to cause serious long term side effects. Plenty of research works have been carried out in relation to the Shamana treatment as directed in Ayurveda and their therapeutic effect is proved. Many more herbal combinations are described in Ayurveda and their therapeutic effect in Kasa is yet to be explored. According to nation family health survey of Bihar 2019-20 prevalence of acute respiratory tract infection among children is 3.5% compared to 2.5% in 2015-2016 surveyed. Acharya Charaka defines Kasa as; "Kasanath Kasaha The production of abnormal sound in the process of release of Vayu that was obstructed is termed as Kasa". Acharya Sushruta defines Kasa as "Sambhinna kamsaya swanatulya ghosha" the disease that produces a typical sound, which mimics the sound produced from a broken bronze vessel. In modern medical science cough is defined as cough is a sudden, often, involuntary, forceful release of air from the lungs. Drakshadi churna and Talishadi churna are such Herbo-combination mentioned proved to be cure against kasa. They are explained specially in the context of kasa in children and said to be very effective in curing them so in context of recurring disorders present study is aimed at Kasa as it is most recurrent in childhood, Therefore, the present research work entitled. "A Randomized, double blind, parallel group study comparing the efficacy of Drakshadi Churna and Talishadi Churna in the management of Kasa w.s.r to Recurrent Upper Respiratory Tract Infection of Viral Origin in children." |