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STUDY OF PINAK IN COVID 19 PATIENTS AS ADJUVANT TREATMENT

Simple Randomized control parallel arm study design


PI: DR SHREEPAD BHAT HOD MED. SKNMC & GH, PUNE
COPI: DR KSHIRSAGAR BAMS, SKNMC & GH, PUNE
DR PANDURANG SHRIRANG PAWAR, M.S.(SURG)
EX MEDICAL SUPDT. SDK KARAD, SASOON HOSPITALS, PUNE,
SKNMC & GH NARHE, PUNE. EX DY. DIRECTOR OF HEALTH
SERVICES, PHD MAHARASHTRA
----------------------------------------------------
PINAK IS HERBAL, ORAL/SUBLINGUAL, NON – TOXIC
(LD50>2000MG/KG), NO INTEREACTIONS, PROCESS PATENTED,
USEFUL FOR PREVENTION / FIRST AID / CURE, EXPERTISE NOT
REQUIRED, WATER SOLUBLE AND STABLE AT R.T. ANTIVENIN
AVAILABLE ONLY IN INDIA. NEUTRALISES NEUROPARALYSIS OF
SNAKE BITE IN 12 MINUTES
PINAK
1. HYPOTHESIS OF ACTION: 1.Protein precipitation hypothesis
2.Enzyme inactivation 3. Chelation 4. Adjuvant action 5. Anti
oxidant 6. Protein folding 7.Combination……..
2.In Ayurveda, viral infection is treated as VISH / poison.
3. Covid 19, a Corona virus, attaches to host cells by ‘S’ proteins
4. PINAK ATTACKS ‘S’ PROTEIN AND ‘S’ PROTEIN BECOMES
INEFFECTIVE, HENCE ACTION.
5. URTI IS MOST COMMON PRESENTATION. Other Symptoms are
breathlessness, fever, GI symptoms including Pancreatitis, MI,
CVA, Myalgia, conjunctivitis and skin rash SINGLI OR IN
COMBINATION.
Pinak study Group n = 47 Control Group n = 33
Group Group
Details Studied Total Details Studied Total
Mild pts studied Mild Pts studied
Asympto 16 16 Asymptomat 12 12
matic ic
Enrolled 21 18
Enrolled 31 22
Omitted as 9 Transferred 3
took more ayurvedic To Covid
drugs ICU as they
worsened
Studied 22 Studied 18
Total studied 38 Total studied 30

MODERATE & SEVERE


PINAK Study group = 19, Control group = 19

TOTAL STUDIED PATIENTS = PINAK 38+19 & CONTROL 30+19 = 106/118


Effect of Pinak on symptomatic relief (days required) in MILD CASES.
Pinak Control
Parameter t p
(n=22) (n=18)
Symptomatic <
3.14(1.8) 6.39(3.6) -5.29
relief 0.01*
*Statistically significant

Day Pinak group Control group


2 4 1
3 4 1
4 6 2
5 3 3
6 2 2
7 2 2
8 0 3
9 1 3
10 0 1
Showing no. of patients symptom free on
Day from Date of Admission
NO. OF PATIENTS
7

4
Control group
Pinal group
3

0
2 3 4 5 6 7 8 9 10
DAY

EARLY RECOVERY
Showing NUMBER of patients becoming symptom free on
respective day from DAY OF PINAK STARTED
Day symptoms Pinak study Control group
relieved group
2 10 1
3 6 1
4 2 2
5 3 3
6 0 2
7 1 2
8 0 3
9 0 3
10 0 1
NO. OF PATIENTS
12

10

Control group
6
Pinak study group

0
2 3 4 5 6 7 8 9 10

Showing number of patients becoming DAY


symptom free on respective day from
DAY OF PINAK STARTED.
EARLY RECOVERY
Significantly Early Recovery in patients
who had taken PINAK as compared to
Control group
Day Pinak ( n = 22) Control (n = 18) p*
of % %
sympt
omati
c
Cumulative

Cumulative
frequency

frequency
Recov
ery

3rd 16 72.73 2 11.11 <


day * 0.05
5th 21 95.45 7 38.89 <
day * 0.05
7th 22 100.0 11 61.11 <
day 0* 0.05
*Significantly Early
Fisher or Recovery
Mid – P exact tests
OUTCOME IN MODERATE AND SEVERE CASES
Pinak study group ( n = 19) Control group (n = 19)
Transferred Transferred
Discharged
Discharged Non Covid Death Non Covid Death
ICU/Ward ICU/ Ward

Pts. 2 (ICU), 10 2 (ICU),


15 0 3
2 ward 4 ward
Total 15 4 10 6 3
0
(79%) (21%) (52.6%) (31.6%) (15.8%)

Significance for ventilator time and Indoor Stay in Days:

Pinak Control
Parameter t p
(n=19) (n=19)
Ventilatory time 3.89(3.1) 12.53(6.4) 5.07 < 0.01‫٭‬
Indoor Stay 13.47(4.3) 16.42(6.0) 2.06 < 0.05‫٭٭‬
• Significant** Highly significant
COMPLICATIONS
Complications Pinak Group Control group Total
Moderately severe Moderately severe
Acute Renal 1 (5.26%) 2 (10.52%) 3
failure
Dialysis 0 2 (10.52%) 2
DIC 0 0 0
Cardiac 0 2 ( 10.52) 2
complication
Surgical 0 1 (5.26%) 1
intervention/
Tracheostomy

Ventilatory 3.89 Days, 12.53 Days --


assistance/ O2 SD= ± 3.1 SD= ± 6.4
mean Duration

Death 0 3 (15.78%) 3
DISCUSSION IN MILD & MODERATELY SEVERE GROUP:
• Effect of drug Pinak on symptomatic relief is STATISTICALLY
SIGNIFICANT. (t= - 5.29, p = <0.01) In Pinak study group, symptomatic
relief is seen in 3.14 days while Control group showed symptomatic
relief in 6.39 days.
• There is significantly early recovery in patients who had taken Pinak on
3rd day in 72.73%, on 5th day in 95.45% and on 7th day in 100% patients.
Control group showed relief on 3rd day in 11%, on 5th day in 39% and on
7th day in 61% patients.
• Early Recovery of patients due to Pinak leading to reduced Morbidity
and Mortality is confirmed.
1. RECOVERY WITH PINAK IS 100%, WHILE IN CONTROL GROUP IT IS
84.2%.
2. COMPLICATIONS IN PINAK GROUP ARE ABSENT.
3. IN PINAK GROUP AVERAGE VENTILATORY /O2 TIME IS 3.89 DAYS
AND IN CONTROL GROUP IT IS 12.53 DAYS.
4. AVERAGE STAY IN HOSPITAL IS 13.47 DAYS IN PINAK GROUP WHILE
IN CONTROL GROUP IT IS 16.42 DAYS
5. ICU EXPENDITURE IS REDUCED SIGNIFICANTLY
GENERAL OBSERVATIONS – POST STUDY TREATMENT

• PRINCIPLES OF CORONA VIRUS DISEASE TREATMENT IS JUST


LIKE SNAKE BITE ENVENOMATION.
• IN SEVERE CASES, FIRST 24 HRS TREATMENT SHOULD BE IN
LARGER DOSES WITH CLOSE OBSERVATION OF RECOVERY
FOLLOWED BY TAPERING IMMED.
• HIGHER VIRAL LOAD GIVES RISE TO SEVERE SIGNS AND
SYMPTOMS.
• PATIENTS MAY DIE IN SPITE OF PINAK ARE: 1. THOSE WITH NON
VIABLE ORGAN/S DAMAGE 2. PATIENTS DEVELOPING
SUPERADDED HOSPITAL INFECTION.
• ENDEMICITY OF COVID 19 WILL CONTINUE FOR YEARS.
• ѼѼѼѼѼѼ

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