| CTRI Number |
CTRI/2025/03/083090 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study on Management of Kaphaja Kasa with drug Madhvasava:An open labelled Clinical trial. |
|
Scientific Title of Study
|
A Clinical Study on Kaphaja Kasa with Drug Madhvasava An Open Labelled Clinical Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nihal Kanziya |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Goverment Akhandanand Ayurveda College and Hospital, Ahmedabad |
| Address |
OPD No 4, Kayachikitsa Department, Goverment Akhandanand Ayurveda College, Bhadra, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380001
India |
| Phone |
9426939410 |
| Fax |
|
| Email |
nihalkanziya12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himanshu Kanzaria |
| Designation |
Lecturer, Department of Kayachikitsa |
| Affiliation |
Goverment Akhandanand Ayurveda College and Hospital, Ahmedabad |
| Address |
OPD No 4, Kayachikitsa Department, Goverment Akhandanand Ayurveda College, Bhadra, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380001
India |
| Phone |
8866579316 |
| Fax |
|
| Email |
drhimen2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nihal Kanziya |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Goverment Akhandanand Ayurveda College and Hospital, Ahmedabad |
| Address |
OPD No 4, Kayachikitsa Department, Goverment Akhandanand Ayurveda College, Bhadra, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380001
India |
| Phone |
9426939410 |
| Fax |
|
| Email |
nihalkanziya12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment Akhandanand Ayurveda College, Ahmedabad , Gujarat 380001 , India |
|
|
Primary Sponsor
|
| Name |
Goverment Akhandanand Ayurveda College, Ahmedabad |
| Address |
OPD No 4, Department of Kayachikitsa, Goverment Akhandanand Ayurveda College, Bhadra, Ahmedabad. |
| 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 |
| Nihal Kanziya |
Goverment Akhandanand Ayurveda College |
OPD No 4, Department of Kayachikitsa , Goverment Akhandanand Ayurveda College, Bhadra, Ahmedabad, Ahmedabad, Gujarat 380001
Ahmadabad
GUJARAT |
9426939410
nihalkanziya12@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:J00-J99||Diseases of the respiratory system. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madhvasava, Reference: Bruhat Trayi and Sarandhar Samhita, Route: Oral, Dosage Form: Asava, Dose: 15(ml), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -15 ml muhurmuhu dose (6-8 times/day) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate and give written informed consent.
Patients in the age group of 18-70 years of either sex.
Patients with signs and symptoms of Kaphaj Kasa
|
|
| ExclusionCriteria |
| Details |
Patients below 18 yrs & above 70 yrs.
Patients having Pneumonia, Pulmonary Tuberculosis, Pneumothorax, Pleural effusion, Bronchial Asthma, COPD, Bronchiectasis, etc.
Any congenital anomalies related to respiratory or cardiovascular systems.
The patient suffering from malignant systemic disorders.
Patients having Uncontrolled HTN, Poorly controlled Diabetes mellitus, Unstable Angina, Coronary artery disease.
Red Flag Signs associated with Cough: Hemoptysis, Breathlessness, Weight Loss, Fever.
Patients having severe Renal or any Hepatic disease.
Pregnant or lactating females.
Any other serious systemic disease.
Any acute systemic disease or Infection, with post covid lung disease/complication.
Acute and serious conditions which require emergency intervention will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the symptoms of kaphaja kasa |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the symptoms of kaphaja kasa |
Day 7
Day 15 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/04/2025 |
| 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="8"
Days="15" |
|
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
|
In the pathogenesis of disease Kaphaj Kasa, vitiated Kapha obstructs the free flow of Vayu in Kantha and Uras. Since Kapha is the main culprit in the production of Kasa indulgence in food and activities which aggravate Kapha increases the severity of Kaphaj Kasa. Exposure cold environment, sleeping in daytime usually aggravates Kaphaj Kasa. Thus Vata and Kapha are the two key pathological factors involved in the Samprapti of Kaphaj Kasa. Kaphaj Kasa is the clinical entity in which there is coating of cough in mouth, Kapha sampoorna ura (feeling of phlegm collected in the chest), aversion to food, feeling of heaviness of the body, debility, cough followed by thick sputum.
Madhvasava having Chedi, Tikshna, Kaphaghna and kasahara effects, thus eliminating episodic recurrence of kaphaja kasa and provide a cure from disease to the patient.
Diagnostic Criteria Kanthoplepa Asya madhurya Pinasa Vaksh sampurnaiv manyate Ghana – snigdha – sweta – bahul shleshm pravarthanam Aruchi Excess quantity of Sputum
Present study is being planned to evaluate the study on Kaphaja kasa with drug Madhvasava. The sample size is 40 patients. Madhvasava will be given in 15 ml dose in muhur muhur dose (6-8 times / day). Study duration is of 7 days and follow up after 7 days. Study Design is Open Labelled Clinical Trial.
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