| CTRI Number |
CTRI/2025/08/093404 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on managment of vataja kasa |
|
Scientific Title of Study
|
A Clinical Study on the Efficacy of Oral
Rasna Ghritam in the Management of Vataja Kasa
|
| 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 MUGGULLA ANUSHA |
| Designation |
POSTGRADUATE IN KAYACHIKITSA |
| Affiliation |
DR.B.R.K.R. GOVT AYURVEDIC MEDICAL COLLEGE and HOSPITAL, HYDERABAD |
| Address |
DEPARTMENT OF KAYACHIKITSA OPD,
DR.B.R.K.R. GOVT AYURVEDIC MEDICAL COLLEGE and HOSPITAL, HYDERABAD, TELANGANA, INDIA, PINCODE 500038
DEPARTMENT OF KAYACHIKITSA OPD,
DR.B.R.K.R. GOVT AYURVEDIC MEDICAL COLLEGE and HOSPITAL, HYDERABAD, TELANGANA, INDIA, PINCODE 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
09849913420 |
| Fax |
|
| Email |
anusha.muggulla13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K LAXMIKANTHAM |
| Designation |
PROFESSOR,MD AYURVEDA, DEPARTMENT OF KAYACHIKITSA |
| Affiliation |
DR.B.R.K.R. GOVT AYURVEDIC MEDICAL COLLEGE and HOSPITAL, HYDERABAD |
| Address |
ADDRESS:
DEPARTMENT OF KAYACHIKITSA, OPD ROOM NO 2, DIVISION 2, DR.B.R.K.R. GOVT AYURVEDIC MEDICAL COLLEGE and HOSPITAL, HYDERABAD, TELANGANA, INDIA, PINCODE 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9989398463 |
| Fax |
|
| Email |
drlaxmikantham20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR K LAXMIKANTHAM |
| Designation |
PROFESSOR,MD AYURVEDA, DEPARTMENT OF KAYACHIKITSA |
| Affiliation |
DR.B.R.K.R. GOVT AYURVEDIC MEDICAL COLLEGE and HOSPITAL, HYDERABAD |
| Address |
ADDRESS:
DEPARTMENT OF KAYACHIKITSA, OPD ROOM NO 2, DIVISION 2, DR.B.R.K.R. GOVT AYURVEDIC MEDICAL COLLEGE and HOSPITAL, HYDERABAD, TELANGANA, INDIA, PINCODE 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9989398463 |
| Fax |
|
| Email |
drlaxmikantham20@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.B.R.K.R. GOVT AYURVEDIC MEDICAL COLLEGE & HOSPITAL, HYDERABAD, TELANGANA, INDIA, 500038 |
|
|
Primary Sponsor
|
| Name |
DR MUGGULLA ANUSHA |
| Address |
DEPARTMENT OF KAYACHIKITSA OPD ROOM NO 2 DIVISION-2, DR.B.R.K.R. GOVT AYURVEDIC MEDICAL COLLEGE and HOSPITAL HYDERABAD, TELANGANA, INDIA 500038 |
| 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 MUGGULLA ANUSHA |
DR.B.R.K.R.GOVT AYURVEDIC MEDICAL COLLEGE & HOSPITAL, HYDERABAD |
DEPARTMENT OF KAYACHIKITSA, OPD ROOM NO 2, DIVISION-2, DR.B.R.K.R. GOVT AYURVEDIC MEDICAL COLLEGE & HOSPITAL, HYDERABAD, TELANGANA,500038
Hyderabad
TELANGANA |
09849913420
anusha.muggulla13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Dr BRKR Government Ayurvedic Medical College and Hospital |
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: VATAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: RASNA GHRITAM, Reference: CHARAKA CHIKITSA KASA CHIKITSA ADHYAYA 18/43-46, Route: Oral, Dosage Form: Ghrita, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: LUKE WARM WATER), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
1.Patients with age group between 18 to 65 years of either gender.
2.Patients presenting with Lakshanas of Vataja Kasa viz
Shushka kasa (Dry cough)
Shushka Kanta Vaktra (Dryness in throat and mouth)
Swarabheda (Hoarseness of Voice)
Kshinabala (Weakness)
Hrit shoola (Pain in the Cardiac region)
Parshwa shoola (Pain in the flanks)
Urah shoola (Pain in the Chest region) and
Shira shoola (Headache).
•Patients who are willing to participate in the clinical study & sign in the consent form
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1.Patients aged below 18 years and more than 65 years.
2.Patients with Severe Systemic diseases, COPD, Bronchial Asthma, Pulmonary Tuberculosis, Malignancy, Cardiac Asthma.
• Pregnant women and lactating mothers.
• Other types of kasa.
• Severe Pneumonia.
• Chronic lung infection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the frequency of episodes of cough |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To provide relief from the clinical features of Vataja kasa. |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anusha.muggulla13@gmail.com].
- For how long will this data be available start date provided 08-08-2025 and end date provided 24-05-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
• Respiratory diseases emerge as notable challenges, impacting individuals across various life stages with varying degrees of severity. • Kasa, a condition attributed to disturbances in the Prana vaha Srotas due to Amashaya-related imbalances, underscores the intricate nature of these ailments. The harmonious operation of the Prana and Udana Vayu holds the key to the proper functioning of the Prana vaha Srotas. Disruptions in this balance, brought about by causative factors, precipitate the onset of Kasa. • Within the framework of Samprapti, the pathway of Prana vata faces obstructions from factors such as Dhuma and Rajah, acting as irritants to the Prana vaha Srotas which further gets aggravated in association with other doshas is expelled out forcefully with a sound like the “Bhinna Kansya svana thulya” i.e., “broken bronze vessel", called as Kasa. • The intricate cough reflex, involving both motor and sensory pathways mediated by Prana and Udana vata, further underscores the complex nature of this ailment. • According to Acharya Charaka, lakshanas of Vatajakasa are Hrit-Parshwa- Urahsula, Shirasula, Swarabheda, SushkaUrah-kanta-vaktra, Hrushtalomanah, Nirghosha,Dainyastanana, Dourbalya, Kshobha, Moha, Sushka Kasa, Shushka Kapham. • Kasa may develop either as an independent disease, a lakshana associative to other diseases or as Upadrava of a disease. Understanding and differentiating the Kasa, is most important to treat the condition effectively. |