| CTRI Number |
CTRI/2025/02/081050 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study efficacy of Dashmool Kwath in Kaphaja Pratishyaya ( Chronic Rhinitis ) in children |
|
Scientific Title of Study
|
A Randomized, Controlled ,Clinical Study Of Efficacy Of Dashmool Kwath In The Management Of Kaphaja Pratishyaya In Children With Special Reference To Chronic Rhinitis |
| 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 SUPREMA RAJENDRA SONWANE |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Ayurvedic College And Hospital,Nanded |
| Address |
Department of Kaumarbhritya ,Government Ayurvedic College and Hospital,Nanded.Vazirabad,Nanded.
Nanded
MAHARASHTRA
431601
India |
| Phone |
7020705858 |
| Fax |
|
| Email |
sonwanesuprema91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SUPREMA RAJENDRA SONWANE |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Ayurvedic College And Hospital,Nanded |
| Address |
Department of Kaumarbhritya ,Government Ayurvedic College and Hospital,Nanded.Vazirabad,Nanded.
Nanded
MAHARASHTRA
431601
India |
| Phone |
7020705858 |
| Fax |
|
| Email |
sonwanesuprema91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dattatraya Bhaurao Chavan |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College And Hospital ,Nanded |
| Address |
Department of Kaumarbhritya,Government Ayuvedic College and Hospital,Nanded.Vazirabad ,Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9422174644 |
| Fax |
|
| Email |
drdbchavan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital,Vazirabad Nanded pin -431601 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
DrSuprema Rajendra Sonwane |
| Address |
Department of Kaumarbhritya,Government Ayuvedic College and Hospital,Nanded.Vazirabad ,Nanded,Maharashtra ,India. Pincode - 431601 |
| 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 Suprema Rajendra Sonwane |
Government Ayurvedic College And Hospital ,Nanded,Maharashtra ,India . |
Department of Kaumarbhritya, ,Nanded.Vazirabad ,Nanded.
Nanded
MAHARASHTRA |
7020705858
sonwanesuprema91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Government Ayurved College,Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashmool Kwath, Reference: Ashtang Hridaya Uttarsthan 20/1, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vyoshadi Vati , Reference: Ashtang Hridaya Uttarsthan 20/5, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group – 5yrs to 15 yrs of both sexes.
2.Patients having 2 or more than 2 symptoms of Kaphaja Pratishyaya including nasastrava for more than 2 weeks like -
1.Nasastrava (Rhinorrhea)
2.Nasavrodha (Nasal obstruction)
3.Shoonakshi (Oedema of eye)
4.Kasa (Cough)
5.Kandu (Itching)
6.Aruchi (Anorexia)
7.Jwara ( Fever )
3.Patients selection will be irrespective of socioeconomic status and gender.
|
|
| ExclusionCriteria |
| Details |
1) Severe cases of Rhinitis including sinusitis,pulmonary TB,CSF Rhinorrhea etc.
2) Other systemic,endocrine disorders associated with any degree of Kaphaja Pratishyaya
3) Severely ill patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Dashmool Kwath to reduce main symptoms of Kaphaja Pratishyaya i.e. rhinorrhoea in children with special reference to Chronic Rhinitis . |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access clinically efficacy of Dashmool Kwath to reduce symptoms of kaphaja pratishyaya other than rhinorrhoea like kasa,aruchi,kandu,jwar in children |
14 Days |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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="2"
Months="0"
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 randomized controlled clinical study to evaluate the efficacy of dashmool kwath in kaphaja pratishyaya in children.Dashmool Kwath when taken orally as per age of requirement to the age group 5 years to 15 years twice a day after meal for 14 days. follow up on 7th,15th and 21st day.this study will be carried out in 2 years of PG course. |