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CTRI Number  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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: tiltail, Reference: charak samhita sutrasthan 13/12, Route: Rectal, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: tiltail, Reference: charak samhita sutrasthan 13/12, Route: Rectal, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information:
(3) Medicine Name: triphala kwath, Reference: sushrut samhita sutrasthan 38/56,57, Route: Rectal, Dosage Form: Kwatha/ Kashaya, Dose: 750(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information:
(4) Medicine Name: triphala kwath, Reference: sushrut samhita sutrasthan 38/56,57, Route: Rectal, Dosage Form: Kwatha/ Kashaya, Dose: 750(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information:
(5) Medicine Name: kshirbala tail, Reference: charak samhita chikitsasthan 29/119,120, Route: Rectal, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information:
(6) Medicine Name: kshirbala tail, Reference: charak samhita chikitsasthan 29/119,120, Route: Rectal, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information:
(7) Medicine Name: brihatpanchmul siddha kshir, Reference: sharangdhar samhita purvakhanda 4/1, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 750(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information:
(8) Medicine Name: brihatpanchmul siddha kshir, Reference: sharangdhar samhita purvakhanda 4/1, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 750(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information:
(9) Medicine Name: brihatpanchmul siddha kshir, Reference: sharangdhar samhita purvakhanda 4/1, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 750(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  • 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" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/09/2021 
Date of Study Completion (India) 13/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
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) Yog  Basti Kram

       Brihat Panchmul Siddha

          Kshir Niruha

        Kshirbala  Tail Anuvasan

   3) Kalyanak Ghrit Rasayan.

 

Local Abhayng + Shiroabhyanga  Local 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 Rasayana  for 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.

 1] FSS Scale                                                          

 2]MMRC dyspnea scale                           

 3]Chest pain scale                                                       

 4]VAS Scale                                          

 5]Smell and taste scale                      

 6]WOMAC scale                                               

 7]Hamilton depression scale                         

 8]Hamilton anxiety scale 

 9]Insomnia severity index 

10] Cough severity index 

11] Facial ageing scale 

12] Dizziness scale 

13] Pittsburge severity quality index 

14] Functional Status scale

15]Heart palpitation scale 

 
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