| CTRI Number |
CTRI/2025/04/085796 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the effect of Dasamoolasati rasnadi kashayam and Manibhadra gulam in improving the quality of life and pulmonary functions of Chronic Obstructive Pulmonary Disease subjects |
|
Scientific Title of Study
|
Effectiveness of Dasamoolasati rasnadi kashaya and Manibhadra gulam in improving the quality of life of COPD subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Najma A S |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College, Tripunithura |
| Address |
Department of Kayachikitsa
Government Ayurveda College
Tripunithura, Ernakulam
Kerala
India
Ernakulam
KERALA
682301
India |
| Phone |
9656584902 |
| Fax |
|
| Email |
najmaabdulsalam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shylamma T M |
| Designation |
Professor, Department of Kayachikitsa |
| Affiliation |
Government Ayurveda College, Tripunithura |
| Address |
Department of Kayachikitsa
Government Ayurveda College
Tripunithura, Ernakulam
Kerala
India
Ernakulam
KERALA
682301
India |
| Phone |
9446400969 |
| Fax |
|
| Email |
drtmshylamma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shylamma T M |
| Designation |
Professor, Department of Kayachikitsa |
| Affiliation |
Government Ayurveda College, Tripunithura |
| Address |
Department of Kayachikitsa
Government Ayurveda College
Tripunithura, Ernakulam
Kerala
India
KERALA
682301
India |
| Phone |
9446400969 |
| Fax |
|
| Email |
drtmshylamma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College, Tripunithura, Ernakulam, pin code- 682301, Kerala |
|
|
Primary Sponsor
|
| Name |
Najma A S |
| Address |
Department of Kayachikitsa, Government Ayurveda College, Tripunithura, Ernakulam |
| Type of Sponsor |
Other [PG Scholar(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 |
| DrNajma A S |
Department of Kayachikitsa |
Government ayurveda Hospital, Tripunithura, Ernakulam, Pin-682301, Kerala
Ernakulam
KERALA |
9656584902
najmaabdulsalam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH, Government Ayurveda College, Tripunithura, Ernakulam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J449||Chronic obstructive pulmonary disease, unspecified. Ayurveda Condition: SVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manibhadra gulam, Reference: Ashtanga Hridayam, Chikitsa sthana chapter 19, sloka no:31, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -12 gm jaggery), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dasamoola satirasnadi kashayam, Reference: Ashtanga Hridaya chikitsa sthana 4th chapter,sloka no:25, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed clinically and as per investigations of COPD , stage 1 and 2 as per GOLD criteria of spirometry |
|
| ExclusionCriteria |
| Details |
subjects known to have allergic asthma, malignancy
subjects with peak expiratory flow rate less than 50% |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quality of life of COPD subjects using SGRQ
|
0th(before treatment),15th,31st(after treatment),45th day(follow up)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pulmonary functions using spirometry |
0th(before treatment), 15th, 31st(after treatment), 45th day(follow up) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
26/05/2025 |
| 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 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
|
The subjects will be selected on the basis of inclusion and exclusion criteria. They will be assessed on the basis of degrees of spirometric abnormalities and SGRQ. The subjects will be given Dasamoola satirasnadi kashaya and Manibhadra gulam for a period of 30 days. The improvement in the quality of life and pulmonary functions of the subject will be evaluated on 0th day, 15th day and 31st day. follow up will be done on 45th day. |