| CTRI Number |
CTRI/2025/06/089387 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Compare Efficacy of Dhanyak Sita Yoga versus Dhanyak sita yoga with Tandulodak for managing Kasa (Acute Bronchitis) in Childrens. |
|
Scientific Title of Study
|
A Clinical trial Compare to the efficacy of Dhanyak Sita Yog with or without Tandulodak Anupan 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 Neetu Rathour |
| Designation |
MD Scholar |
| Affiliation |
PG Department of Kaumarbhritya State Ayurvedic College Lucknow |
| Address |
PG Department of Kaumarbhritya, State Ayurvedic College Lucknow Tulsidas Marg Turiyaganj Lucknow Uttarpradesh India pin code 226004
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8127811475 |
| Fax |
0 |
| Email |
dr.rathourneetu997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Gautam |
| Designation |
Reader PG department of Kaumarbhritya |
| Affiliation |
PG Department of Kaumarbhritya State Ayurvedic College Lucknow |
| Address |
PG Department of Kaumarbhritya, State Ayurvedic College Lucknow Tulsidas Marg Turiyaganj Lucknow Uttarpradesh India pin code 226004
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9450361310 |
| Fax |
0 |
| Email |
gautamramesh09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neetu Rathour |
| Designation |
MD Scholar |
| Affiliation |
PG Department of Kaumarbhritya State Ayurvedic College Lucknow |
| Address |
PG Department of Kaumarbhritya, State Ayurvedic College Lucknow Tulsidas Marg Turiyaganj Lucknow Uttarpradesh India pin code 226004
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8127811475 |
| Fax |
0 |
| Email |
dr.rathourneetu997@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department of Kaumarbhritya, State Ayurvedic College Lucknow Tulsidas Marg Turiyaganj Lucknow Uttarpradesh India pin code 226004 |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic college and Hospital Lucknow |
| Address |
PG Department of Kaumarbhritya, State Ayurvedic College Lucknow Tulsidas Marg Turiyaganj Lucknow Uttarpradesh India pin code 226004 |
| 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 Neetu Rathour |
State Ayurvedic College and Hospital Lucknow |
PG Department of Kaumarbhritya, State Ayurvedic College Lucknow Tulsidas Marg Turiyaganj Lucknow Uttarpradesh India pin code 226004
Lucknow
UTTAR PRADESH |
08127811475
dr.rathourneetu997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Ethics Committee, State Ayurvedic College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J209||Acute bronchitis, unspecified. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhanyak Sita Yog, Reference: Bhavprakash Madhyam Khand Chi.8, Route: Oral, Dosage Form: Churna/ Powder, Dose: 200(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Tandulodak), Additional Information: -Tandula jala (rice wash) is obtained by soaking and squeezing one pala broken rice in eight times its quantity of water. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhanyak Sita Yog, Reference: Bhavprakash Madhyam Khand Chi.8, Route: Oral, Dosage Form: Churna/ Powder, Dose: 200(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -Dhanyak Sita Yog without anupan |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects irrespective of gender, religion, socioeconomic status and between the age group of 3-10 years were being taken.
2.Subjects having classical signs and symptoms of Kasa.
3.Subjects of Kasa with chronicity of less than 7 days duration (Acute cases only)
Note- Only those patients willing to give a written informed consent as well as follow the study procedures were included in the study. |
|
| ExclusionCriteria |
| Details |
1.Patients having Kasa (Acute bronchitis) as Upadrava or Anubandha lakshana (complication) of other systemic diseases.
2.Patients suffering from any severe disease of lower respiratory tract infection.
3.Patients/ parents not coming for follow-up or not taking medicine as directed.
4.Patients presenting with symptoms of, Kshayaja and Kshataja Kasa.
5.Serious cardiovascular, cerebrovascular, renal and liver diseases or severe illness.
6.Any chronic illness diseases of respiratory system eg. TB, Respiratory Distress Syndrome, Chronic lung disease, Bronchiectasis, Pleurisy etc
7.Patients suffering from any systemic disorder (like Diabetes Mellitus etc.) and Kasa as a complication of any disease will be excluded from the study
8.Children with any congenital abnormality.
9.History of food or drug allergy of any kind. |
|
|
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 |
| To compare the efficacy of Dhanyak sita yog with or without Tandulodak anupan in the management of kasa(Acute bronchitis) in children. |
3rd day,7th day, and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To find the nature (Dosha) of cough associated symptoms with cough as the chief complaint.
2. To mointor any adverse effect of trial drug.
3. To study the concept of kasa through Ayurvedic and modern text
4.To provide a reliable, effective, harmless Ayurvedic treatment for kasa roga |
3rd day,7th day, and 15th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/07/2025 |
| 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="5"
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 - NO
|
|
Brief Summary
|
This is a Randomised comparative open label,parallel group phase 2 clinical study.Comparing the efficacy of Dhanyak Sita Yog along with Tandulodak and Dhanyak Sita Yog alone in cases of Kasa for 15 days in 60 patients .The patient fulfilling the clinical criteria for diagnosis of Kasa will be randomly selected irrespective of their sex, caste, and religion from OPD/IPD of state Ayurvedic College and Hospital, Lucknow and referred cases from other hospitals. A careful history, physical examination and necessary investigation will be performed .Further patients divided in to two groups ,Group A - In this group "DHANYAK SITA YOG" WITH TANDULODAK ANUPAN will be given orally in doses of 200 mg per kg per day after breakfast or meal.Group B-In this group" DHANYAK SITA YOG" WITHOUT TADULODAK ANUPAN will be given orally in doses of 200 mg per kg per day after breakfast or meal. Drugs will be provided in dry form in a packet which is sufficient for treatment dose . Follow up will be done after every 3rd day, 7th days of treatment for each group. |