Clinical Study of Sars Cov-2019 Nosode -Part III Clinical Trial of Sarscov-2019 Nosode (06 Ck) on Healthy Individuals

This is part three of a series of three articles. Part 3 is about evidence-based homoeopathy. It is to study and illustrate the effect of SarsCov-2 19 Nosode in 06 CK in a Before-After study with relation to inflammatory markers associated with Covid-19 infection in a small group of healthy individuals.

Part I was published in the September 2020 issue of this journal. Part 1 is about evidence-based homoeopathy, depicting associated inflammatory markers of 10 cases that are corrected by SarsCov-2 19 Nosode (SCN) in treatment of acute Covid-19 infection. Part I is about proving efficacy of SCN in 30 CK, a high potency, in disease. The 30 CK according to Avogadro’s number cannot have in it even traces of the starting material.

Part 2 is published also in this October 2020 issue. Part 2 is about evidence-based homoeopathy, depicting laboratory findings that are corrected by SarsCov-2 19 Nosode 30 Ck in treatment of Post Covid-19 sequelae (ILF- 2 cases).

Keywords: SarsCov-2 19 Nosode 06CK, clinical proving, before-after, healthy humans, inflammatory markers, Covid-19, safe, effective

Summary: I have conducted 28 provings in 28 years of my homoeopathic practice in different potencies such as 12 Ck, 30 Ck, 200 Ck, 50 millesimal potencies.  I was considering conducting a proving of the new medicine Sarscov-2 19 Nosode (SCN) that I prepared in June 2020.

I came across the proving notes on Covid-19 Nosode of Marilyn Freedman and Hannah Shalom (Toronto, Canada) conducted in March 2020 in 1M and 10 M potency.  Therefore, I decided to prove this medicine differently so that it aligns with the evidence-based medicine era trend. The method used was to prove the Nosode in low potency, 06 CK and record its effects in a before-after study with relation to inflammatory markers in healthy individuals.

I didn’t want my study to be hindered by the dictates of Avogadro’s number and so I chose the 06 Ck potency. The dictate of Avogadro’s number is that chemically all potencies above 12 C will be just the vehicle and contain none of the original material.

Hahnemann’s Organon, 6^th Edition, Boericke’s translation aphorism §108 on drug proving says…

Aphorism § 108

There is, therefore, no other possible way in which the peculiar effects of medicines on the health of individuals can be accurately ascertained – there is no sure, no more natural way of accomplishing this object, than to administer the several medicines experimentally, in moderate doses, to healthy persons, in order to ascertain what changes, symptoms and signs of their influence each individually produces on the health of the body and of the mind; that is to say, what disease elements they are able and tend to produce1, since, as has been demonstrated (§§ 24-27), all the curative power of medicines lies in this power they possess of changing the state of man’s health, and is revealed by observation of the latter”.

Part III: Drug Proving: This is essentially a proving of SCN in 06 CK. This study was aimed at ascertaining the effects of the SarsCov-2 19 Nosode in 06 CK on inflammatory markers associated with Covid-19 in healthy humans.

In any proving, we need to ascertain ‘symptoms and signs’ (§ 108); A symptom is subjective, that is, apparent only to the patient. A common example is burning pain or nausea. A sign is any objective evidence of a disease that can be observed by others. A common example is a skin eruption or redness secondary to inflammation of the eye.

In my interpretation, a sign can also mean changes in blood chemistry, haematology, pathology and histology. With the proving of SCN 06 Ck, I was aiming to ascertain symptoms and signs of its influence on the health of the individuals. My emphasis is on the ‘signs’. The subjective symptoms that volunteer code RSP, JG and KDW exhibited are mentioned collectively in the article after the study on inflammatory markers.

Why 06 CK potency?

Mother tinctures and all dilutions contain alcohol, as do the orally administered drops prepared in an alcohol solution. Alcohol is effective against influenza virus. Ethyl alcohol (70%) is a powerful broad-spectrum germicide and is considered generally superior to isopropyl alcohol.

The Sarscov-2 19 Nosode is prepared in 90%v/w of ethyl alcohol. 06Ck is diluted to 10 raise to -12 (10^-12) while being succussed at each step. In this circumstance the virus has no scope to be active and potent to affect the individual adversely.

Let us understand the scale of our homoeopathic dilutions…

Centesimal Scale  1:100	Ratio of dilution	Special Note
1C	1: 100	Low potency
3C	10 raised to -6 (10-6)
4C	10 raised to -8 (10-8)	Allowable concentration of Arsenic in US drinking water that is 0.05 mg/L
6C	10 raised to -12 (10-12)	Applying the equation of 12C we have in 6C a more than 100% possibility of containing more than one molecule of original material if one mole of the original substance was used
The Avogadro constant (NA or L) is the proportionality factor that relates the number of constituent particles (usually molecules,  atoms  or ions) in a sample with the amount of substance in that sample. Its SI unit is the reciprocal mole, and it is defined as NA = 6.02214076×1023 mol−1
12C	10 raised to -24 (10-24 )	Has a 60% probability of containing one molecule of original material if one mole of the original substance was used.
One mole of a substance is equal to 6.022×1023   units of that substance (such as atoms, molecules or ions)
30C	10 raised to – 60 (10-60)	Dilution advocated by Dr Hahnemann

In the 06 CK of the SCN, we definitely have a more than 100% possibility of containing more than one molecule of original material if one mole of the original substance was used. In homoeopathic proving the molecule of original material is being introduced in an open system, the gastrointestinal tract. The study is to ascertain what effect the molecule of original material will have on the immune system of the individual ingesting it (refer to table above).

Schema of Study

The clinical study (drug proving) of SCN in 06 Ck pertains to evaluating its effect in 12 healthy human beings before and after receiving the medicine orally. The healthy individuals who volunteered were tested before and after for inflammatory markers.

1. Before: Inflammatory markers (CBC, ESR, CRP, SGOT, SGPT, Ferritin and igG for Covid or AntiSarscov-2 Antibodies ) before the ingestion of medicine. The tests were conducted to verify that they did not have the predisposition to be potential candidates for Covid-19 infection.
2. After 8-10 days: CBC, ESR, CRP and Anti Sarscov-2 Antibodies to be repeated between 8-12 days of receiving of SCN 06CK.

3. After 14-18 days: AntiSarscov-2 Antibodies to be repeated between 14-18 days after receiving of SCN 06CK. Testing 8-10 days and 14-18 days after is based on the available information that IgG antibodies are produced from day 5 to 7 of the infection and levels peak around 10 to 14 days post infection and last for several months. A new study from Iceland provides reassurance that our antibodies to the coronavirus that causes covid-19 can last at least four months.

 Figure:  Estimated variation over time in diagnostic tests for detection of SARS-CoV-2 Infection relative to symptom onset Source: https://jamanetwork.com/journals/jama/fullarticle/2765837

THE SURPRISE

In all, 12 members volunteered for this study. The ‘Before’ bloodwork of 6 of them established them as reactive for Anti SarsCov-2 antibody and the other 6 were Non-reactive for Anti SarsCov-2 antibody. The 6 reactive volunteers were not known to have suffered from the Covid-19 disease. I was surprised, and I also considered disqualifying the 6 Reactive to AntiSarsCov-2 antibody. On second thought, I decided to flow with what was unfolding. I included all 12 (6 Reactive +6 Non-reactive for Antibody) in the 06CK SCN study.

INSTRUCTIONS FOR THE HEALTHY SUBJECTS GROUP:

1. One pill daily of 06 CK SCN for 5 days at bedtime (from 26 August to 30 August 2020).
2. To continue their regular medication in volunteers who have pre-existing illness (diabetes, hypertension etc.). Volunteer Code DBK is on blood thinners/ anti platelets as he had an angioplasty a year ago. He was asked to stop his homoeopathy medicines.
3. To continue with their daily routine, continue with their regular diet and regimen
4. The study group was not isolated during and were following their occupation as usual and following the lockdown rules laid by the state government.
5. Only subject ARS was residing in Surat, Gujarat. All the others were residents of Mumbai, Maharashtra.
6. All other homoeopathy medicines were discontinued by volunteers during this drug proving. Volunteer Code KGN suffering from tinnitus and stopped all homoeopathy.

Comparison of the inflammatory markers’ values before and after taking the medicine in 06 CK.

Table 1: After 5 days of SCN 06Ck in Non-reactive group
PEI=Pre Existing Illness: R=Reactive: NR=Non reactive B=Before A=After
	RSP	KDS	ADS	GSJ	DBK	KGN
Sex	F	M	M	F	M	F
Age	49	32	28	44	73	59
Profession	Lawyer	Lawyer	Lawyer	Housewife	Doctor	Doctor
PEI	DM	Fatty Liver & Dyspepsia		Adenomyosis on OC pills	DM+ HT+IHD	Tinnitus
Hb-B	10.4	14.9	14.3	13.3	13.7	12.38
Hb-A	10.8	15.4	14.5	14.1	13.6	13.2
WBC-B	9000	10500	8100	9500	7200	8280
WBC-A	9200	9700	6900	8800	5500	8300
Neutro-B	72	62	55	61	68	44
Neutro-A	71	63	55	62	67	61
Lympho-B	19	37	44	38	30	49
Lympho-A	19	36	44	36	32	37
ESR-B	7	10	18	35	25	45
ESR-A	11	20	35	40	36	50
CRP-B	2.4	1.1	1.5	3.03	0.5	3.9
CRP-A	2.9	1.4	1.8	2.0	0.5	4.0
SGOT-B only	20	40.1	27	18	38.4	28
SGPT- B only	13	93	44	10.7	25.1	30.1
Ferritin – B only	80.2	189	68	15.03	247	132.46
AntiSarscov-2 antibodies -B	NR (0.0771)	NR 0.072	NR 0.103	NR 0.083	NR 0.209	NR 0.082
AntiSarscov-2 antibodies -After- 8th to 10th  Day	NR (0.0785)	NR 0.085	NR 0.112	NR 0.087	NR 0.176	NR (0.066)
AntiSarscov-2 antibodies -After- 14th    -18th Day	NR (0.0687)	NR (0.0)	NR (0.04)	NR (0.072)	NR (0.070)	NR (0.065)

 STUDY ON REACTIVE GROUP

Table 2: After 5 days of SCN 06Ck in Reactive group
PEI=Pre Existing Illness: R=Reactive: NR=Non reactive B=Before A=After
	CNS	JG	SJG	DRD	ARS	KDW
Sex	F	M	M	M	M	F
Age	53	51	25	41	47	53
	Doctor	Shop owner	Student	Doctor	Doctor	Artist
PEI		HT			Asthma
Hb -B	12.65	15.1	16.1	13.5	15.2	10.9
Hb-A	13.9	15.2	16.0	13.0	15.2	11.0
WBC-B	9550	5900	8100	5300	6410	6400
WBC-A	9900	6300	7700	5200	5450	6100
Neutro-B	50	63	53	57	60	63
Neutro-A	67	67	56	55	54	59
Lympho-B	44	36	46	32	33	36
Lympho-A	32	32	42	33	36	40
ESR-B	35	15	10	6	10	50
ESR-A	33	12	05	9	10	55
CRP-B	1.1	0.5	0.5	3.9	01	1.4
CRP-A	0.6	0.5	0.5	4.47	01	1.6
SGOT-B	38.1	29	30.1	40	12	22.1
SGPT-B	41	31	43.1	49	12	26.1
Ferritin -B	35.82	47.27	84.81	86.2	137	79.26
AntiSarscov-2 antibodies -B:	React 63.90	React 18.74	React 118.8	React 4.70	React 1.04	React 57.41
AntiSarscov-2 antibodies -A:  8thto 10th Day	React 57.70	React 18.90	React 118.6	React 64.6	React 1.83	React 51.01
Code DRD showed a significant rise in reactive value. All other volunteers showed an insignificant change in reactive values
AntiSarscov-2 antibodies -A : 14 th to 18th Day	Since most subjects showed an insignificant change in reactive values the test was not repeated.

SUBJECTIVE SYMPTOMS OBSERVED AFTER 5 DAYS OF SCN 06 CK:

Volunteers with code RSP, JG and KDW mentioned some symptoms that are listed below. Others did not exhibit any symptoms at all.

1. Feverish feeling but no recorded temperature. Hot feeling in the body.
2. Eyes heavy.
3. Body ache; Body feels heavy, feet feel heavy while walking, no desire to walk. Energy levels very low. Tired feeling all the time.
4. Body and mind felt sluggish, no desire to work
5. Sleep fitful, wakes up often due to aches and pains.
6. Rumblings in abdomen. Bowels regular but feels clear.

CONCLUSION: EFFECT OF SCN 06 CK ON HEALTHY HUMANS   

1. Part I and II of this article demonstrated the curative powers of SCN 30 CK in disease. The SCN is effective as a medicine in Covid-19 infection.
2. The above study in healthy human beings (Part III) demonstrated the following…

Observation 1: The SCN 06 CK did not alter the inflammatory markers in the 12-member study group- both Reactive and Non-reactive group.  

Deduction 1: That SCN 06 Ck has no adverse effect even at such low potency. The SCN even at low potency 06CK is safe.

Observation 2: The SCN 06CK did not adversely alter the reactivity in the 06 member study group that was Reactive to AntiSarsCov -2 Antibodies   before starting the study.

Deduction 2: Only in 1 subject (code DRD) was there a significant rise in the antibody titer from 4.70 to 64.6. The SCN 06CK also did not adversely alter the titer value of Antibodies (by causing reduction) in the 6-member study group that was Reactive to AntiSarsCov -2 Antibodies. The SCN even at such low potency as 06Ck is safe and has no adverse effects on the antibody titer.

Observation 3: The SCN 06CK did not alter the Non-reactivity in the  06-member study group  that was Non-reactive to AntiSarsCov -2 Antibodies  before starting the study.

Deduction 3: That SCN 06Ck has no adverse effect even at such low potency. The SCN even at low potency 06CK is safe.

CONCLUSION:  SCN 06 CK is safe and has no adverse effect in healthy individuals.

FINAL CONCLUSION: Part I of this series regarding Study I proved the efficacy of the SarsCov-2 19 Nosode 30 CK in correcting the inflammatory markers associated in the Covid-19 disease. The 30 CK potency of SCN defied Avogadro’s number and still proved to be effective. It passed the test of its capability of assisting the vital force in curing the disease.

                                        Part II of the article with cases proved the efficacy of the Sarscov2-19 Nosode in treating sequelae to Covid-19 infection- Lung damage-ILF. The 30 CK potency of SCN passed the test of its capability of assisting the vital force in curing the disease.

Part III of this  series regarding drug proving in healthy human beings, proved the safety of Sarscov-2 19 Nosode in low potency, as low as 06CK.

THIS STUDY PROVES: SARSCOV-2 19 NOSODE IS SAFE AND EFFECTIVE.

Note: This is the first phase of study with a sample group of 12 individuals. These findings along with all laboratory investigations will be submitted to the appropriate regulatory bodies / authorities in homoeopathy. This drug trial has been self-funded. The plan is to conduct the study with more than 50 healthy individuals. The finances for laboratory investigations for study in a larger group call for support from CCRH/ AYUSH ministry / government institutions.  I am continuing treating Covid-19 active cases and its sequelae in my clinic with SCN and will submit another article on the same in the near future with many more cases.

For more information, contact Dr. Chetna Shukla:

[email protected] 

References:

1. https://medcraveonline.com/IJCAM/avogadro-limit-washed-out-by-nano-associates-of-water-which-continue-as-information-carriers-in-serial-dilutions-and-end-up-with-generalized-concept-of-medicines.html
2. https://mumbaimirror.indiatimes.com/ coronavirus/ news/cured-of-covid-22-return-to-kem-with-pulmonary-fibrosis/articleshowprint/ 77340422 .cms? prtpage=1: Mumbai Mirror 4 August 2020:
3. https://www.thehindubusinessline.com/news/world/90-of-recovered-covid-19-patients-in-wuhan-still-have-damaged-lungs-study/article32302989.ece#: Hindu Business
4. Tocilizumab:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7243567/
5. Tocilizumab: https://en.wikipedia.org/wiki/Tocilizumab
6. https://www.who.int/news-room/ commentaries/detail/immunity-passports-in-the-context-of-covid-19?gclid=EAIaIQobChMIu9Pzjd-d6wIVCCQrCh2K0gHQEAAYASAAEgKwnPD_BwE:Immunity passports in the context of COVID-19
7. https://www.futurity.org/war-zones-stress-babies-1099502/: Darlene Kertes
9. https://www.britannica.com/science/Avogadros-number
10. Use of disinfectants: alcohol and bleach: . nlm.nih. gov/ books/ NBK214356/
11. 20for% 20persons%20who%20test,SARS%2DCoV%2D2%20infection.
12. Interpreting Diagnostic Tests for SARS-CoV-2: Figure on : Estimated Variation Over Time in Diagnostic Tests for Detection of SARS-CoV-2 Infection Relative to Symptom Onset : https://pubmed.ncbi.nlm.nih.gov/32374370/
13. COVID-19 Antibodies Last for at Least Four Months After Recovery: https://www.the-scientist.com/news-opinion/covid-19-antibodies-last-for-at-least-four-months-after-recovery-67907
14. Infection: articlekey=12923