| CTRI Number |
CTRI/2025/02/080925 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Chitrakadi Churna & Mishyadi Churna in the Management of Kasa in Children |
|
Scientific Title of Study
|
A Comparative Clinical Study on the Efficacy of Chitrakadi Churna & Mishyadi Churna in the Management of Kasa 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 |
Dr Nagendra Thakre |
| Designation |
Assistant Professor |
| Affiliation |
Sam College of Ayurvedic Sciences & Hospital, Raisen |
| Address |
OPD no 104 Department of Kaumarbhritya Block C Sam Global University Village Agariya Chopda Block Sanchi District Raisen M P India 462046
OPD no 104 Department of Kaumarbhritya Block C Sam Global University Village Agariya Chopda Block Sanchi District Raisen M P India 462046
Bhopal
MADHYA PRADESH
462046
India |
| Phone |
09981625741 |
| Fax |
|
| Email |
nagen.raj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Mishra |
| Designation |
Professor |
| Affiliation |
Mandsaur Institute of Ayurveda Education & Research |
| Address |
OPD No 4 Department of Shalya Tantra Mandsaur Institute of Ayurveda Education & Research Mandsaur University Rewas Dewada Road SH 31 Mandsaur M P India
Mandsaur
MADHYA PRADESH
458001
India |
| Phone |
8839664965 |
| Fax |
|
| Email |
arunmisra2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Mishra |
| Designation |
Professor |
| Affiliation |
Mandsaur Institute of Ayurveda Education & Research |
| Address |
OPD NO 4 Department of Shalya Tantra Mandsaur Institute of Ayurveda Education & Research Mandsaur University Rewas Dewada Road Sh 31 Mandsaur M P India
Mandsaur
MADHYA PRADESH
458001
India |
| Phone |
8839664965 |
| Fax |
|
| Email |
arunmisra2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sam College of Ayurvedic Sciences & Hospital Village Agariya Chopada Block Sanchi District Raisen M P India 462046 |
|
|
Primary Sponsor
|
| Name |
Dr Nagendra Thakre |
| Address |
Sam College of Ayurvedic Sciences & Hospital Village OPD No 104 Department of Kaumarbhritya Block C Sam Global University Agariya Chopada Block Sanchi District Raisen M P India 462046 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Arun Mishra |
Mandsaur Institute of Ayurveda Education & Research OPD No 4 Department of Shalya Tantra Mandsaur University Rewas Dewada Road Sh 31 Mandsaur MP India 458001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nagendra Thakre |
SAM Hospital |
Depatment of Kaumarbhritya C block OPD no 105
Raisen
MADHYA PRADESH |
09981625741
nagen.raj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MISHYADI CHURNA, Reference: CHAKRADATTA BALROGAADHIKAR 46/63, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: -MADHU), Additional Information: -PATIENT WILL BE GIVEN MISHYADI CHURNA IN A DOSE OF 1.5 TO 12 gm in 6 Divided Doses for 7 Days. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: CHITRAKADI CHURNA, Reference: CHAKRADATTA BALROGAADHIKAR 53/70, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: -MADHU), Additional Information: -PATIENT WILL BE GIVEN CHITRAKADI CHURNA IN A DOSE OF 1.5 TO 12 GM IN 6 DIVIDED DOSES FOR 7 DAYS. |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1 The patients having classical symptomatology of Kasa Roga.
2 The patient under 16 years of age irrespective of caste, religion, sex, habits, socioeconomic status & those who fulfill the diagnosis will be selected for the study.
3 Children will be diagnosed on the basis of following symptoms of Kasa mentioned in classical texts, in addition to the signs and symptoms mentioned in contemporary texts.
Kasa severity
Shira shoola
Aruchi
Swarbheda
Shukpurna Gala Aashyata
|
|
| ExclusionCriteria |
| Details |
1. Patients above 16 years of age.
2. Acute Patients with infection will be excluded.
3. Patient suffering from Kshtaja and Kshayaja Kasa.
4. Patient suffering with any chronic disorder as Pneumonia, COPD (Chronic Obstructive Pulmonary Disorder), Emphysema, Bronchiectasis.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of Chitrakadi Churna & Mishyadi Churna in the Management of Kasa in Children |
Base Line (Visit 1 ) to end of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
the efficacy of Chitrakadi Churna in management of kasa roga, Shirashoola, Swarabheda, Aruchi, Shukapurnagalaasyata, CBC & absolute eosinophil count.
the efficacy of Mishyadi Churna in management of kasa roga, Shirashoola, Swarabheda, Aruchi, Shukapurnagalaasyata, CBC & absolute eosinophil count. |
Base Line (visit 1) to end of treatement. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/02/2025 |
| 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 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 a open, simple, randomized clinical trial enrolling 100 subjects divided equally into 2 groups. Patients fulfilling the inclusion criteria will be enrolled for study. Group A will be administered with Chitrakadi Churna in a dose of 1.5 to 12 gm in 6 divided doses and Group B will be administered with Mishyadi Churna in a dose of 1.5 to 12 gm in 6 divided doses for 7 days. The efficacy of the treatment will be evaluated on basis of various assessment criteria like Kasa severity, Shira shoola, Aruchi, Swarbheda, Shukpurna Gala Aashyata. The result will be assessed with regards to improvement recorded in clinical findings. Assessment will be done by adopting proper statistical tools. The primary outcome of trial will be to compare the effect of Chitrakadi Churna & Mishyadi Churna in the Management of Kasa in
Children. |