| CTRI Number |
CTRI/2020/05/025341 [Registered on: 24/05/2020] Trial Registered Prospectively |
| Last Modified On: |
06/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to know the effect of Ayurvedic Kwath(Kiratiktadi Kwath) & Ashwagandha Churna along with yoga exercises in the treatment of COVID-19 Positive patients. |
|
Scientific Title of Study
|
Efficacy of Kiratiktadi Kwath & Ashwagandha Churna with Yoga modalities
in management of COVID -19 patients.
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Ankur Singhal |
| Address |
Department of Kayachikitsa,
GS Ayurveda Medical College & Hospital, NH-9, NEAR RAILWAY STATION,
POST-PILKHUWA
DISTRICT- HAPUR
Ghaziabad
UTTAR PRADESH
245304
India |
| Phone |
09760768689 |
| Fax |
|
| Email |
drankursinghal2015@gmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Ankur Singhal |
| Address |
Department of Kayachikitsa,
GS Ayurveda Medical College & Hospital, NH-9, NEAR RAILWAY STATION,
POST-PILKHUWA
DISTRICT- HAPUR
Ghaziabad
UTTAR PRADESH
245304
India |
| Phone |
09760768689 |
| Fax |
|
| Email |
drankursinghal2015@gmail.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Ankur Singhal |
| Address |
Department of Kayachikitsa,
GS Ayurveda Medical College & Hospital, NH-9, NEAR RAILWAY STATION,
POST-PILKHUWA
DISTRICT- HAPUR
Ghaziabad
UTTAR PRADESH
245304
India |
| Phone |
09760768689 |
| Fax |
|
| Email |
drankursinghal2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mrs. Sonali Sharma,
The Managing Director
GS Ayurveda Medical College & Hospital, Pilkhuwa
District-Hapur |
|
Primary Sponsor
Modification(s)
|
| Name |
NO |
| Address |
NIL |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankur Singhal |
GS Ayurveda Medical College & Hospital |
GS Ayurveda Medical College & Hospital, NH-9, Near Railway Station, Post-Pilkhuwa,
District-Hapur
Ghaziabad
|
09760768689
drankursinghal2015@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Coronavirus as the cause of diseases classified elsewhere |
| Patients |
Coronavirus infection, unspecified |
| Patients |
Other specified viral diseases |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1) Kiratiktadi Kwath 30 ml twice a day before food for 14 days.
2)Ashwagandha churna 5gm before sleep with luke warm water. for 14 days
3) Yoga exercises 45 min twice a day empty stomach for 14 days.
4)Immunobooster Ayush Kwath as ministry of ayush guidlines 40 ml once a day (early morning , empty stomach) |
1) Kiratiktadi Kwath as mentioned in sharngdhar samhita in kwath prakaran.
2) Aswagandha churna as mentioned in rasayan adhikar in chakradatt tika.
3) Yoga exercises including pranayam, suryanamaskar etc. as per MDNIY, NEW DELHI |
| Comparator Agent |
MODERN TREATMENT as per UP Govt Norms to asymptomatic and mild cases. |
MODERN TREATMENT as per UP Govt Norms to asymptomatic and mild cases. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) COVID 19 positive cases with mild symptoms or Asymptomatic
2) Age: above 20 yrs or below 60 yrs of either sex.
|
|
| ExclusionCriteria |
| Details |
1) Cases suffering from any co morbidities.
2) Age below 20 or above 60 yrs
COVID -19 negative cases.
3) If the patient develops any systemic side effects.
Symptoms of COVID-19 aggravated to moderate level during study.
4) Moderate and Severe patients of COVID-19 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Kiratiktadi Kwath & Ashwagandha Churna with yoga modalities in the management of mild and asymptomatic cases of COVID-19 Patients |
approx 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rate of recovery with ayurvedic management as compared to modern treatment. |
approx 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2020 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
no |
|
Brief Summary
|
EFFICACY OF KIRATIKTADI KWATH & ASHWAGANDHA CHURNA WITH YOGA MODALITIES IN THE MANAGEMENT OF COVID-19 PATIENTS. Management includes: Guggulu dhoopan twice a day in COVID-19 wards. Ayush Kadha as herbal tea once a day early morning. Yoga sessions twice a day. Kirtikatdi kwath 30 ml twice a day. Ashwagandha churna 5gm once a day with lukewarm water. Specific diet plan. |
