| CTRI Number |
CTRI/2025/04/085766 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
To study the add on effect of Gudshuntyadi Yog in Tamaka Shwasa with special reference to Total Leucocyte Count and Differential Leucocyte Count |
|
Scientific Title of Study
|
Randomised controlled clinical trial to assess add on effect of Gudshuntyadi Yog in Tamaka Shwasa with special reference to Total Leucocyte Count and Differential Leucocyte Count |
| 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 Heena Riyaz Jamadar |
| Designation |
PG scholar |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center Address LRP Ayurvedic medical college and hospital, PG Institute and Research center |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute
and Research Centre Islampur Department of Rognidan,Division No
.1,Room No 1 ,Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
7744007866 |
| Fax |
|
| Email |
heenajamadar008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gouri Mohite |
| Designation |
HOD and Professor |
| Affiliation |
LRP Ayurvedic Medical College and Hospital, PG Institute and Research center |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Department of Rognidan,Division No.1 ,Room No 1 ,Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8806073556 |
| Fax |
|
| Email |
gaurimohite492@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Heena Riyaz Jamadar |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College and Hospital |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Department of Rognidan,Division No 1 ,Room No 1 ,Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
7744007866 |
| Fax |
|
| Email |
heenajamadar008@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur
415409
|
|
|
Primary Sponsor
|
| Name |
Dr.Heena Riyaz Jamadar |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and
Research center, Urun Islampur 415409
|
| 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 |
| DrHeena Riyaz Jamadar |
LRP Aurvedic medical college and hospital, PG Institute and Research center, Urun Islampur |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute
and Research Centre Islampur Department of Rognidan,Division No
1 ,Room No 1 ,Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
415409
India
Sangli
MAHARASHTRA |
7744007866
heenajamadar008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre, Islampur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gudshuntyadi Yog, Reference: Ashtang Hridayam Hikkashwas Chikitsa Adhyay, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna Jal), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Salbutabol and Theophylline | Dose-2/100mg,BID for 30 days |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient of Age group 20 to 60 years of age irrespective of cast, religion,
gender, habitat, occupation & socio-economy status.
2) Patient in avega awastha (non-acute phase)
3) Patient having signs & symptoms of Tamaka shwasa (Bronchial Asthma)
known case of Asthma not more than 1yr.
4)Patient on treatment of Asthma (Salbutamol+ theophyllin) 1BD
|
|
| ExclusionCriteria |
| Details |
1)The patient having age group below 20 yrs & more than 6oyrs
2) Patient with Urdhva ,Maha, Chinna, Kshudra shwas.
3) Patients having other systemic disorders like Diabetes Mellitus,
Carcinoma, Pulmonary T.B., Hepatitis.
4)Patients in vega avatha.
5)Serious Asthmatic patient needs emergency treatment.
6)Pregnant & lactating mother.
7)Shwasa due to secondary origin.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study add on effect of Gudshuntyadi yog in Tamaka shwasa with special reference
to total leukocyte count and differential leucocyte count.
|
30 days study with follow up on 15th,and 30th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study Tamaka shwasa according to ayurvedic literature.
2) To study Bronchial asthma according to modern science.
3) To study, respiratory rate, peak expiratory flow rate,total leukocyte count
and differential leucocyte count.
4) To study relief in Tamaka shwasa by using Gudshuntyadi yog and changes
in, respiratory rate, peakexpiratory flow rate,total leukocyte count and
differential leucocyte count in Tamaka shwasa by using Gudshuntyadi yog |
30 days study with follow up on 15th,and 30th day
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
09/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/05/2025 |
| 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 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
|
PRIMARY OBJECTIVE To study add on effect of Gudshuntyadi yog in Tamaka shwasa withspecial reference to total leukocyte count and differential leucocyte count.
SECONDARY OBJECTIVES 1) To study Tamaka shwasa according to ayurvedic literature. 2) To study Bronchial asthma according to modern science. 3) To study, respiratory rate, peak expiratory flow rate,total leukocyte count and differential leucocyte count. 4) To study relief in Tamaka shwasa by using Gudshuntyadi yog and changes in, respiratory rate, peakexpiratory flow rate,total leukocyte count and differential leucocyte count in Tamaka shwasa by using Gudshuntyadi yog.
TYPE OF STUDY DESIGN: Open randomized controlled clinical study will be done.
Study setting: OPD of Kayachikitsa and Panchkarma in our college.
Study population: Random selection of patient by even odd method having Tamaka shwasa will be selected,data will be collected according to objective of the study in the case paper.Prevalence rate of Tamaka shwasa is 2.5%
Duration of Treatment: 30days.
METHODOLOGY: The proposed study will be done in follow levels.
Drugs and diseases Review:
The drug and disease review will be taken from Ayurvedic classical texts and from modern literature, research paper, research article, medical journals and related website.
Clinical Trials: Assessment, screening, selection, randomization and follow-up patients with intervention and investigation and documentation.
SUBJECTIVE CRITERIA: 1) Ghurghurtvum 2) Kasa 3) Dukhen kapha nissaran 4) Uraha peeda 5) Nidranash
OBJECTIVE CRITERIA: 1) Respiratory rate. 2) Peak expiratory flow rate value. 3) Total leucocyte count 4) Differential leucocyte count.
METHODS OF DATA COLLECTION: The criteria of assessment will be based on subjective and objective parameter. Data analysis, plan & method: 1. Observations and results will be done with various graphs, diagrams, chart and tables of observations. 2. Statistical analysis will be based on Paired t statistical test for objective parameter and Wilcoxon signed rank test for subjective parameter.
Collection and preparation of drug: Drug will be procruited by GMP approved pharmacy Equal quantity of Guda and Shunthi will be taken from GMP Approved pharmacy
Discussion : Obtained data will be discussed
Conclusion: It will be done strictly on the result obtained during the study.
Summary : On the basis of observations, discussion and results summary will be drawn and whole dissertation work will be summarized.
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