Basti and Rasayan for Post COVID-19 Syndrome
- Conditions
- Coronavirus infection, unspecified. Ayurveda Condition: jirnajwara,janpadodhwansha, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2021/08/035732
- Lead Sponsor
- Government Ayurved College and Hospital
- 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,
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| --- | --- |
|***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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
- •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.
- •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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 18 month 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. 18 month 3. To compare symptoms of Santarpanottha and Apatarpanottha Post COVID-19 Syndrome at the time of recruitment. 18 month
- Secondary Outcome Measures
Name Time Method To review the Ayurvedic Concepts of Post COVID-19 syndrome. 18 month
Trial Locations
- Locations (1)
Government Ayurved College and Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Government Ayurved College and Hospital🇮🇳Nagpur, MAHARASHTRA, IndiaDr Payal RathodPrincipal investigator8888744418pr2217692@gmail.com