CTRI/2021/08/035732 [Registered on: 17/08/2021] Trial Registered Prospectively
Last Modified On:
21/02/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Other
Public Title of Study
Basti and Rasayan for Post COVID-19 Syndrome
Scientific Title of Study
Clinical Evaluation of Basti along with Rasayana on symptoms of Post COVID-19 Syndrome.Open Labelled Proof of Concept Pragmatic Study.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Payal Rathod
Designation
PG 1st Year
Affiliation
Government Ayurved College,Nagpur
Address
Under Guidance of Dr Amit Nakanekar in Department of Kayachikitsa OPD number 1,Government Ayurved College and Hospital,Sakkardara square, Nagpur
Nagpur MAHARASHTRA 440029 India
Phone
8888744418
Fax
Email
pr2217692@gmail.com
Details of Contact Person Scientific Query
Name
Amit Nakanekar
Designation
Assistant Professor
Affiliation
Government Ayurved College,Nagpur
Address
Department of Kayachikitsa, OPD Number 1, Government Ayurved College and Hospital,Sakkardara square,Nagpur.
Nagpur MAHARASHTRA 440029 India
Phone
9850233016
Fax
Email
amitnakanekar@gmail.com
Details of Contact Person Public Query
Name
Payal Rathod
Designation
P.G. Scholar
Affiliation
Government Ayurved College ,Nagpur
Address
Department of Kayachikitsa,OPD number 1, Government Ayurved College and Hospital,Nagpur.
Nagpur MAHARASHTRA 440029 India
Phone
8888744418
Fax
Email
pr2217692@gmail.com
Source of Monetary or Material Support
Government Ayurved College and Hospital,Nagpur.
Primary Sponsor
Name
Government Ayurved College and Hospital
Address
Government Ayurved College and Hospital,Sakkardara Square,Nagpur
Type of Sponsor
Other [Government Ayurved College and Hospital]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Payal Rathod
Government Ayurved College and Hospital
Department of Kayachikitsa, OPD number 1,Government Ayurved College and Hospital,Raje Raghuji Nagar Sakkardara square,Nagpur. Nagpur MAHARASHTRA
8888744418
pr2217692@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Government Ayurved College Ethics committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:B342||Coronavirus infection, unspecified. Ayurveda Condition: jirnajwara,janpadodhwansha, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,
• Patients of Post COVID-19 Syndrome came under duration of >21 days to 1 year after RTPCR report
• Patient of either sex aged between 18-70 years. irrespective of caste, religion , socio economic and educational status.
• Patient of Post COVID-19 Syndrome having > 20 % (> 4) of symptoms will be included for the study.
• Patient of Post COVID-19 Syndrome who are willing to participate in trial and ready to give written consent.
ExclusionCriteria
Details
• Patients with serious lifethreatening diseases and critically ill patients of Post COVID-19 Syndrome will be excluded.
• Pregnant females and lactating mothers will not be considered for study.
• Basti Anarhya will be excluded for study.
• Patient who have known hypersensitivity reactions to medicines mentioned in the study will be excluded.
• Any other patient which investigator feels not to be included will be excluded from study.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1. To evaluate the efficacy of Triphala Kwath Niruh Basti, Tiltail Anuvasan Basti and Brahma Rasayana on symptoms of Santarpanottha Post COVID-19 Syndrome in period of 35 days.
2. To evaluate the efficacy of Brihatpanchmulsidhha Kshirbasti ,Kshirbala tail Anuvasan Basti and Kalyanak Ghrit on symptoms Apatarpanottha Post COVID-19 Syndrome period of 35 days.
3. To compare symptoms of Santarpanottha and Apatarpanottha Post COVID-19 Syndrome at the time of recruitment.
18 month
Secondary Outcome
Outcome
TimePoints
To review the Ayurvedic Concepts of Post COVID-19 syndrome.
18 month
Target Sample Size
Total Sample Size="24" Sample Size from India="24" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="24"
Nakanekar A, Rathod P. The clinical evaluation of Basti along with Rasayana on symptoms of post-COVID-19 syndrome: an open-labeled proof of concept pragmatic study-a study protocol. Pilot Feasibility Stud. 2023 Jun 3;9(1):92. doi: 10.1186/s40814-023-01322-1. PMID: 37270514; PMCID: PMC10238229.
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
After clearance from Institutional Ethics Committee of Government Ayurved college, Nagpur and CTRI Approval, A pragmatic open labelled study will be conducted on 24 subjects of Post COVID-19 Syndrome diagnosed by assessing Santarpanottha and Apatarpanottha will recruited from OPD,IPD, Casualty and periphery of Government Ayurved College, Nagpur.
During the informed consent process the subjects will given enough time to read patient information sheet and consent form. subjects would also given freedom to ask the questions and all the questions would answered. If he/she agrees for participation in the study and if found fit to include during screening then he/she will recruited in the study. This visit called as screening visit.
On screening visit, after written informed consent, screening of subject on the basis of clinical assessment for Santarpanottha and Apatarpanottha along with symptoms of Post COVID-19 Syndrome and fulfilling the diagnostic criteria . If all inclusion criteria is YES and all exclusion NO then subjects will be included on the basis of criteria given as BMI > 25 (Santarpanottha) and BMI<25 (Apatarpanottha)
Subjects would then undergo general and systemic examinations. Clinical symptoms of post COVID-19 Syndrome will assessed and recorded in the CRF. Study design will be pragmatic i.e., practical approach in our knowledge , No pragmatic trial has been conducted on Post COVID-19 Syndrome . Our hypothesis for this study is Basti and Rasayana has effect on immunity and metabolism and can modulate Santarpanottha and Apatarpanottha types of pathological processes if two different types of approaches will be used.
Pachan ,Yog Bastikram and Rasayana treatment will be given in subjects assessed by clinically and divided in two group i.e,
Santarpanothha
Apatarpanottha
1) Guggulutiktak Kashayam
2)Yog Basti Kram-
Triphala Niruha-
Til Tail Anuvasan
3) Brahma Rasayan
Local Abhayng + Shiroabhyanga local Swedan as Purvakarma for Basti
1) Laghumalini Vasant
2)YogBasti Kram
Brihat Panchmul Siddha
Kshir Niruha
KshirbalaTail Anuvasan
3) Kalyanak Ghrit Rasayan.
Local Abhayng + ShiroabhyangaLocal Swedan as Purvakarma for Basti
Duration of Basti: 08 days
Duration of Rasayana : 21 days ( ½ Mandal)
Time of administration:
Gugglutiktak Kashay and Laghumalini Vasant will be given after the meals.
Triphala kwath Niruh Basti and Brihatpanchmulsiddha Kshir Basti will be administered empty stomach.
Tiltail and Kshirbala tail Anuvasan Basti will be administered after meals .
Brahma Rasayan Kalyanak Ghrit will be given on empty stomach
*Determinants of Dose:
On the basis of Aatur Bal Pariksha Dose of Medicine will be finalized for each patient.
•Range of dose for particular medicines are given in the table.
•Dose of Basti will vary according to Aatur Bal Pariksha+ Basti Pratyagama
Treatment details
Group Santarpanottha
Group Apatarpanottha
1.Pachan – Guggulutikatam kashyam
For 3-5 days
1.Pachan – Laghumalinivasant
For 3 -5 days
2.Yog Basti Krama-For 8 days
Tiltail Anuvasan Basti
Triphala kwath Niruh Basti
2.Yog Basti Krama-For 8 days
Kshirbala tail Anuvasan Basti
Brihatpanchmulsiddha kshirbasti
3.Brahma Rasayanafor 21 days
3.Kalyanak ghrit for 21 days
4.Total days : 34 days
4.Total days : 34 days
Subjects would be called to for follow up visits (i.e. 0th, 5th, 6-14th, 35th days respectively). On every follow up visits subjects undergoes general and systemic examinations ,assessment of clinical symptoms, assessment of scale and physical characters will be done on every follow up visit.
Patient’s and Investigator’s global evaluations for overall improvement will be done on at the end of the study. Tolerability of the trial medicine will be assessed by the investigator and patient at the end of the study. All the patients would be closely monitored for any adverse events/ adverse drug reactions. All the investigations performed at the screening visit would be done on 35th day of the treatment.
Based on the above study procedures observations would be made and recorded in the case record forms for each subject at every follow up. Subjects would be assessed for improvement in various clinical symptoms scales of post COVID-19 Syndrome.
Following Scales will be used for various symptoms.