| CTRI Number |
CTRI/2025/07/090236 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of Cough. |
|
Scientific Title of Study
|
A PHARMACOGNOSTICAL AND CLINICAL STUDY OF ROHISHA Cymbopogon martinii Roxb Wats KWATHA IN THE MANAGEMENT OF 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 |
U Shiva kumari |
| Designation |
PG Scholar |
| Affiliation |
Dr.B.R.K.R GOVT AYURVEDIC MEDICAL COLLEGE |
| Address |
Dravya Guna Department first floor Dr BRKR GOVT Ayurvedic medical college SR Nagar Hyderabad Telangana 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9553813107 |
| Fax |
|
| Email |
uduthanurishivakumari@gmail com |
|
Details of Contact Person
Scientific Query
|
| Name |
A Vijaya lakshmi |
| Designation |
HOD and Professor |
| Affiliation |
Dr.B.R.K.R GOVT AYURVEDIC COLLEGE |
| Address |
Dravya Guna Department first floor Dr BRKR GOVT Ayurvedic medical college SR Nagar Hyderabad Telangana 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9849314525 |
| Fax |
|
| Email |
vijayalakshmiayanam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
U Shiva kumari |
| Designation |
PG Scholar |
| Affiliation |
Dr.B.R.K.R GOVT AYURVEDIC COLLEGE |
| Address |
Dravya Guna Department first floor Dr BRKR GOVT Ayurvedic medical college SR Nagar Hyderabad Telangana 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9553813107 |
| Fax |
|
| Email |
uduthanurishivakumari@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
U Shiva kumari |
| Address |
Dravya Guna Department first floor SR Nagar Hyderabad Telangana 500038 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| A Vijaya lakshmi |
Dr. BRKR. Govt. Ayurvedic hospital and Research Centre, SR Nagar,Hyderabad |
Room no-4
Department of Dravya Guna
Hyderabad-500038, Telangana
Hyderabad
TELANGANA |
9849314525
vijayalakshmiayanam@gmail.com |
| A Vijaya lakshmi |
Govt Ayurvedic Hospital and Research Center,SR Nagar,Hyderabad |
Room No-4
Department of Dravyaguna
Hyderabad
Telangana
Hyderabad
TELANGANA |
09849314525
vijayalakshmiayanam@gmail.com |
| U Shiva kumari |
Govt Ayurvedic Hospital and Research Center,SR Nagar,Hyderabad |
Dr BRKR Govt Ayurvedic Hospital Room no 4 Dravya guna Department
Hyderabad Telangana
Hyderabad
TELANGANA |
9553813107
uduthanurishivakumari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committe of Dr.BRKR Govement Ayurvedic College Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J399||Disease of upper respiratory tract, unspecified. Ayurveda Condition: KASAH, (2) ICD-10 Condition:J399||Disease of upper respiratory tract, unspecified. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rohisha kwatha, Reference: Bhavaprakash nighantu, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient with classical features of Kasa
2 Age limit 18 to 60 years irrespective of gender
3 Patients who are willing to sign the consent form
4 Patients willing to take complete treatment
5 Duration of illness not more than 6 months |
|
| ExclusionCriteria |
| Details |
1 Patients below 18 and above 60 years of age
2 Patients with uncontrolled DM and HTN
3 TB and HIV positive cases and other cardiovascular diseases
4 Patients suffering from chronic infections and malignancy
5 Pregnant women and lactating mothers
6 Patients taking treatment under psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Using of Rohisha kwatha churna for 7 weeks
reduction of high cough,headache,chestpain,throat pain,dry cough,wet cough. |
O day,15th day,3Oth day,45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve the quality of life |
o day, 15th day,30th day |
|
|
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)
|
07/07/2025 |
| 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="0"
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
|
Kasa is one of the diseases described by many acharyas.It is presenting complaint in respiratory disorders. Since kasa involves the movement of Vayu in the upper part of body and also afflicts chest , back and sides of neck is called Kasa roga. In Ayurveda kasa means the production of abnormal sound in the process which may be dry or productive. Kapha and vata plays important role in the production of kasa roga. Kapha due to its picchila guna,guru guna,abhishyandi,snigdha guna,causes obstruction in the prana ,udana vata margas and causes kasa. Kasa is characterized by peenasa, nisteevana, shirovedana ,urahkantavedana ,parshwashoola, swarabheda ,gugurashabdha, teevrakasa, jwaranubhuti,kaphasteevana which are mentioned in different claasical texts. DESIGINING PROGRAME: a.Organoleptic,Phytochemical,Physicochemical and clinical evaluation of whole plant of Rohisha (Cymbopogon martinii (Roxb.) Wats. kwatha churna in Kasa will be studied. b. A single group of 30 subjects will be selected randomly from Dr BRKR Govt Ayurvedic Hospital, SR Nagar, Hyderabad, by processing signs and symptoms of Kasa. c. DOSE: Internal (antah parimarjan) 3gms of kwatha churna (whole plant) given after food twice a day orally. |