| CTRI Number |
CTRI/2025/02/080052 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Kataphala bark (Myrica nagi) to alleviate breathlessness in individuals with Chronic Obstructive Pulmonary Disease. |
|
Scientific Title of Study
|
Evaluating the Efficacy of Kataphala (Myrica Nagi)
in Cigarette Smoke-Induced Chronic Obstructive Pulmonary
Disease in Mice and Clinical Study
|
| 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 Amit Kumar Taraphdar |
| Designation |
Professor, Dept. of Dravyaguna Vijnana, |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P. |
| Address |
Dept. of Dravyaguna Room No. T2, Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P,
294/3/1, A.P.C Road, Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9874849650 |
| Fax |
|
| Email |
atipgaer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kumar Taraphdar |
| Designation |
Professor, Dept. of Dravyaguna Vijnana, |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P. |
| Address |
Dept. of Dravyaguna Room No. T2, Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P,
294/3/1, A.P.C Road, Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9874849650 |
| Fax |
|
| Email |
atipgaer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Haiqua Naushin |
| Designation |
M.D. Scholar Dept. of Dravyaguna Vijnana |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P. |
| Address |
Dept. of Dravyaguna Room No. T2, Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P,
294/3/1, A.P.C Road, Kolkata
Dept. of Dravyaguna Room No. T2, Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P,
294/3/1, A.P.C Road, Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
09681672984 |
| Fax |
|
| Email |
naushinhaiqua@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P, 294/3/1, A.P.C Road, Kolkata - 700009, Government of West Bengal |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
294/3/1, A.P.C Road, Kolkata - 700009 |
| 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 Amit Kumar Taraphdar |
Institute Of Post Graduate Ayurvedic Education and Research at S.V.S.P. Hospital, |
Room No. T2, Dept. of
Dravyaguna 294/3/1,
A.P.C. Road, Kolkata
700009.
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
9874849650
atipgaer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethical Committee, I.P.G.A.E & R, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J441||Chronic obstructive pulmonary disease with (acute) exacerbation. Ayurveda Condition: SVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kataphala Bark, Reference: Bhavaprakash Nighantu, Chapter number 1 - Haritakyadi Varga, Shloka number 180 to 181, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: - Honey), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Theophylline | Theophylline in tablet form - 200mg twice a day after meal at noon and night for 28 days. | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kataphala Bark, Reference: Bhavaprakash Nighantu, Chapter number 1 - Haritakyadi Varga, Shloka number 180 to 181, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients who will agree to follow the study protocol of the informed consent and patients who have the following signs and symptoms
i)cough with sputum
ii) wheezing sound
iii) dyspnoea on deep velocity
iv)breathlessness
|
|
| ExclusionCriteria |
| Details |
below 35 years and above 50 years
pre-existing diabetes, hypertension and other systemic disorders
pregnancy
cardiac disease
tuberculosis
sexually transmitted disease
prostatic hypertrophy
hepatic disease
HIV positive |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the efficacy of Kataphala bark by monitoring the signs and symptoms of patients suffering from Chronic Obstructive Pulmonary Disease. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of test drug on quality of life among the patients suffering from Chronic Obstructive Pulmonary Disease |
28 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/02/2025 |
| 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="0"
Months="8"
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 - NO
|
|
Brief Summary
|
The clinical study, which will take place at OPD of the IPGAE&R at SVSP Hospital, is a randomized parallel group, multiple arm trial of a test drug comparing the efficacy of Theophylline for 28 days in 30 patients with Chronic Obstructive Pulmonary Disease. The primary outcome of the research is to evaluate the therapeutic efficacy of test drug in Chronic Obstructive Pulmonary Disease. The secondary outcome is to determine the safety of the test drug on quality of life among the patients suffering from Chronic Obstructive Pulmonary disease. |