| CTRI Number |
CTRI/2022/11/047588 [Registered on: 23/11/2022] Trial Registered Prospectively |
| Last Modified On: |
22/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study efficacy between Bharangyadi ghrita and Kantakari Ghrita in treatment of Vataja Kasa (Dry cough) |
|
Scientific Title of Study
|
A Randomized Standard Controlled Clinical trial to evaluate efficacy of Bharangyadi Ghrita in Vataja Kasa. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Piyush Manik Pawar |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurveda and Research Centre, Nigdi, Pune. |
| Address |
PDEAs College of Ayurveda and Research Centre kayachikitsa departent third floor Nigdi Pune
PDEAs College of Ayurveda and Research Centre 3rd floor kayachikitsa department Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9175310794 |
| Fax |
|
| Email |
piyushpawar497@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Tarachand Khobragad |
| Designation |
Associate professor |
| Affiliation |
PDEAs College of Ayurveda and Research Centre, Nigdi, Pune. |
| Address |
PDEAs College of Ayurveda and Research Centre Nigdi Pune
PDEAs College of Ayurveda and Research Centre 3rd floor kayachikitsa department Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8378929859 |
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Piyush Manik Pawar |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurveda and Research Centre, Nigdi, Pune. |
| Address |
PDEAs College of Ayurveda and Research Centre Nigdi Pune
PDEAs College of Ayurveda and Research Centre 3rd floor kayachikitsa department Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9175310794 |
| Fax |
|
| Email |
piyushpawar497@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda and Research Centre Nigdi Pune |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurveda and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurveda and Research Centre 3rd floor kayachikitsa department Nigdi Pune |
| Type of Sponsor |
Private 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 Piyush Manik Pawar |
Ayurved Rugnalaya and Sterling Multispeciality Hospital Pune |
ayurved rugnalaya and sterling multispeciality hospital,Sector no 27, kayachikitsa department, opd no 17, nigdi pradhikaran pune 411044
Pune
MAHARASHTRA |
9175310794
piyushpawar497@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J40||Bronchitis, not specified as acuteor chronic. Ayurveda Condition: KASAH, (2) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bharangyadi Ghrita, Reference: Vangsen Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kantakari Ghrita, Reference: Charak Chikitsa 18/35, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with the classical signs and symptoms of Vataj Kasa- Shushka
kasa, Hritshool, Parshvashool, Swarbhed, Kshinabala will be taken for study.
2.Patients with age group between 20-60 years.
3.Patients irrespective of gender, sex, cast, income group and occupation.
|
|
| ExclusionCriteria |
| Details |
1. Patients with known case of Tuberculosis, Chronic Obstructive Pulmonary Diseases
(COPD) like emphysema, bronchitis, bronchiectasis.
2. Patients with age group more than 60 years,
3. Covid 19 positive patients.
4. Patients having uncontrolled Diabetes mellitus (HbA1c more than 8) and
Hypertension (Blood pressure more than 160/110).
5. Immunocompromised patients as AIDS , Cancer etc.
6. Patients with moderate and severe dyspnoea.
7. Patients having SpO2 level below 95%.
8. Patients with hemoptysis.
9. Pregnant ladies and lactating mothers will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the efficacy of Bharangyadi Ghrita 10 ml two times a day after meal with lukewarm water and Kantakari Ghrita 10 ml two times a day after meal with lukewarm water in Vataj kasa for 14 days.
2. To give maximum symptomatic relief to patients after 14 days of treatment
3. Relief from symptoms of vataja kasa like shushka kasa, swarbhed, parshvashool, shirshoola after 14 days of treatment. |
14 days study with two follow ups on 7th and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study the adverse drug effects if any |
14 days study with two follow ups on 7th and 14th day |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
28/11/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Ayurveda has described the pathogenesis and the treatment of various diseases. Vataj kasa is one of such important Pranavaha Srotas (Respiratory System) vyadhi which has impact on today’s era’s quality of life of an individual. Also in this COVID-19 pandemic it is one of the important factors we should think about. Different modalities of treatment have been explained in Ayurveda to tackle this condition effectively. Respiratory system is the system which is in continuous contact with the external environment since birth throughout the lifetime, so it is most vulnerable to infections. As the prevalence of Vataj Kasa is considerable, Vataj Kasa is one of the common complaint and it is also symptom of various diseases of respiratory system. Vataj Kasa though is not life threatening, it troubles human being as it hinders the day to day activities. According to Ayurveda Shaman line of treatment includes oral administration of medicine is of utmost importance as the administration is very easy and also effective. Cough is a reflex of respiratory tract towards stimulation of cough receptors in mucosa of pharynx, larynx, trachea and bronchi by irritants, foreign body or excess secretion. Treatments of cough mainly consist of treating underlying cause whether infective or non-infective. Apart from specific remedy (antibiotics etc.) cough may be treated as a symptom with pharyngeal demulcents, expectorant, antitussive, antihistamines, bronchodilators etc. In Ayurveda, effective management is described in various Ayurvedic Samhitas. Ayurveda has the best medicine and treatment options for Vataj Kasa (Dry cough). If this treatment is started in beginning of symptoms, the disease can be prevented. Many Ghrita, leha, dhuma, peya, pathya and other simple medicines are found which help in management of Vataj Kasa with minimal efforts. The Vataj Kasa is responsible for many diseases, thus to prevent further progress of the other diseases, it is necessary to cure it at first stage. The present study is carried out to evaluate the effect of Bharangyadi Ghrita on Vataj Kasa. This Bharangyadi Ghrita Is described In Vangasen Samhita, Kasa Prakaran. |