Conversion of Phyto-Actives of JRK’s JRK’s 777 Oil Post-Sun Exposure Exhibit Calcipotrial like Activity – A Clinical Comparison at RML Hospital, New Delhi
- 1. Dr. JRK’s Research and Pharmaceuticals Pvt., Ltd., India
Abstract
Psoriasis is an auto immune disorder with the clinical symptoms of scaling, inflammation, itching and dryness. Drugs/medicines used for the psoriasis will be clinically evaluated based on the reduction in the symptoms and overall PASI score which include thichness, redness and itching.
In the present clinical evaluation, the efficacy of Dr.JRK’s 777 oil and Calcipotrial was tested based on the reduction in the clinical symptoms and PASI score.
A total of 26 patients was taken for the study of each drug and given the instructions to use for 12 weeks. The results are monitored on basal PASI, 2nd week, 6th week and 12th week.
Results shows that in both the groups i.e., Dr.JRK’s 777 oil and Calcipotrial ointment there is a great improvement in the clinical symptoms and PASI score by the end of the study where Dr.JRK’s 777 oil had a higher edge without any side-effects.
Complete details are presented in the paper.
Keywords
Dr.JRK’s 777 oil, Psoriasis, Calcipotrial, Wrightia tinctoria, CCRA
Citation
Rajagopal G, Amruthavalli GV (2022) Conversion of Phyto-Actives of JRK’s JRK’s 777 Oil Post-Sun Exposure Exhibit Calcipotrial like Activity – A Clinical Comparison at RML Hospital, New Delhi. J Dermatolog Clin Res 10(1): 1144.
INTRODUCTION
Psoriasis is an incurable autoimmune disease with maximal manifestation in the skin where the skill cells, especially the keratinocytes enters into proliferation phase much before the completion their maturation and cell turnover cycle resulting in the formation of cells with absolute functional abnormalities of the daughter cells [1]. Such cells gather and accumulate over the skin causing hyperkeratotic patches with no benefit to the skin, leading to poor thermo balance and elicitation of various inflammatory reactions.
Siddha system of medicine is not only time tested but is also scientific where the ancient Siddhars through their divine power have evaluated the therapeutic effect of several herbal, mineral, metal and fecal materials of different animals on various diseases.
Dr.J.R Krishnamoorthy, by continuing the legacy of Siddha system of medicine, discovered the usefulness of Wrightia tinctoria leaf oil extract for the treatment of Psoriasis which he later patented along with CCRAS and gifted to NRDC through CCRS to commercialize the technology for human welfare.
Several dermatologists in India were very optimistic about the discovery of Dr.J.R Krishnamoorhty and forwarded voluntarily to evaluate the Wrightia tinctoria based oil which was named as JRK’s 777 oil in order to offer better, quicker and much needed relief to Psoriatic patients.
The Wrightia tinctoria based oil contains innumerous phytosterols and some even have exhibited structural analogue with calcipotrial [2]. On solar exposure the phytosterols turning to Vit D3 analogue and exhibiting calciportrial like activity was the primary premise and which cannot be ruled out and that might be the reason for the therapeutic effect of JRK’s 777 oil, initially the dermatologists presumed.
Before going to the mechanism of action and the possible reasons, the dermatologists at RML Hospital, New Delhi wanted to evaluate the clinical efficacy of JRK’s 777 oil in comparison with calciportriol in same patients as left-right comparison over 12 week of usage. The details of the clinical trial were presented by the dermatologists in 1997 in the National Conference of Dermatologists, Venereologists, Leprologists at Guwahati and the data we have presented in the paper.
The data was never covered in the proceedings of the conference nor has been published elsewhere. The complete data was not presented in the conference as the study was not completed then and hence only highlights alone were presented then and the details are given in the present paper.
MATERIALS AND METHODS
Twenty-six patients with comparable degree of plaque psoriasis both in clinical manifestation and also in duration (chronicity) were empaneled in the study.
All the patients required only topical medicament and the clinical condition of the Psoriasis was amenable to new investigational product of palliative nature.
All the patients were clearly instructed about the trial methodology, objectives, duration (12 week) and got the confirmation to participate in the trial and would follow the compliance.
Two distal anatomical sites with same extent of lesion in each patient were identified. The lesion that can be easily exposed to sunlight was chosen for JRK’s 777 oil application and the other lesion was chosen for calcipotrial application.
Twice daily application of the treatment products was followed in all patients.
The lesion that was treated with JRK’s 777 oil was exposed to sunlight for 15 minutes. At the end of every 4th week, the patients were examined and the progress if any and or any adverse effect was recorded. The statistical significance of the treatment response at different time points of treatment between Dr.JRK’s 777 oil and calcipotriol were calculated using SPSS software and average and standard deviation were calculated for statistical importance.
RESULTS
Out of the 26 patients empaneled into the study, 16 were male and 10 were female patients. The age distribution of the patients was concerned, mostly were between 35- 45 years and small population were between 46-58 years of age. The duration of the disease in all patients ranged from minimum three years to maximum of 6 years (Table 1).
Table 1: Age, gender and duration of the disease distribution. |
||||
Gender |
No. of patients with 3-4 years duration of psoriasis |
No. of patients with 5-6 years duration of psoriasis |
Age in years |
|
32-45 |
46-58 |
|||
Male |
8 |
8 |
10 |
6 |
Female |
5 |
5 |
6 |
4 |
Four-week treatment with JRK’s 777 oil has reduced the psoriatic symptom redness by 40% in 24 patients, thickening by 20% in all 26 patients, scaling by 50% in all 26 patients. In the case of calcipotriol treatment, close to 50% reduction in all the three parameters was observed in all 26 patients (Table 2).
Table 2: clinical response after 4-week treatment. |
||
Clinical parameters |
% reduction and number patients |
|
JRK’s 777 oil treatment (n=26)/SD |
Calcipotriol (n=26) /SDvv |
|
Redness |
40/24 ±0.5 |
50/26±0.4 |
Thickening |
20/26 ± 0.7 |
40/26±0.2 |
Scaling |
50/26 ± 0.2 |
50/26±0.5 |
Eight week treatment with JRK’s 777 oil has reduced the psoriatic symptom redness by 50% in all 26 patients, thickening by 40% in all 26 patients, scaling by 60% in all 26 patients. In the case of calcipotriol treatment, close to 70% reduction in all the three parameters was observed in all 26 patients (Table 3).
Table 3: clinical response after 8-week treatment. |
||
Clinical parameters |
% reduction and number patients |
|
JRK’s 777 oil treatment (n=26) /SD |
Calcipotriol (n=26) /SD |
|
Redness |
50/26 ±0.2 |
70/26 ± 0.2 |
Thickening |
40/26 ±0.3 |
60/26 ± 0.3 |
Scaling |
60/26 ± 0.5 |
70/26 ±0.5 |
Twelve-week treatment with JRK’s 777 oil has reduced the psoriatic symptom redness by 80% in all 26 patients, thickening by 80% in all 26 patients, scaling by 80% in all 26 patients. In the case of calcipotriol treatment, close to 80% reduction in all the three parameters was observed in all 26 patients (Table 4).
Table 4: clinical response after 12-week treatment. |
||
Clinical parameters |
% reduction and number patients |
|
JRK’s 777 oil treatment (n=26) /SD |
Calcipotriol (n=26) /SD |
|
Redness |
70/26± 1.5 |
80/26 ± 0.6 |
Thickening |
70/26 ± 2.2 |
70/26 ±0.4 |
Scaling |
80/26 ± 2.5 |
80/26 ±0.8 |
Although all the 26 patients of both gender with plaque psoriasis responded to both JRK’s 777 oil and calcipotrial by 12- week treatment, but the response was faster in male than female patients in relative terms (Table 5).
Table 5: overall clinical response versus gender. |
||||
Gender |
No |
Positive treatment response/% of patients |
||
Week 4 |
Week 8 |
Week 12 |
||
Male |
16 |
40 |
60 |
100 |
Female |
10 |
20 |
40 |
100 |
Irrespective of the duration of the disease, all the lesions responded to the treatment in a similar manner (Table 6).
Table 6: Treatment response versus duration of the disease. |
|||||
Duration of disease (3-4 years) / no. patients shown positive response, n=12 |
Duration of disease (5-6 years) / no. patients shown positive response, n= 14 |
||||
Week 4 |
Week 8 |
Week 12 |
Week 4 |
Week 8 |
Week 12 |
5 |
12 |
12 |
13 |
13 |
14 |
The above data when compiled in terms of PASI score which includes redness (erythema), thickness (induration) and scaling (desquamation) in 12 weeks, marked decrease of 91.9 % in the PASI* score was observed in JRK’s 777 oil treatment and 90.8% decrease in PASI* score in Calcipotriol treatment (Table 7).
Table 7: PASI score improvement in 12 weeks of treatment. |
||
No. of weeks / mean values |
Dr.JRK’s 777 oil (26 cases) /SD |
Calcipotrial ointment (26 cases) /SD |
Basal PASI |
19.9 ± 0.8 |
19.5 ± 0.7 |
2 weeks |
8.9 ± 1.7 |
8.5 ± 0.2 |
6 weeks |
4.5 ± 2.3 |
4.8 ± 0.3 |
12 weeks |
1.6 ± 2.9 |
1.8 ±0.1 |
*PASI – Psoriasis area severity index |
DISCUSSION
The present clinical evaluation happened purely because of the care and welfare the psoriatic patients deserve the most as felt by the dermatologists at Ram Manohar Lohia Hospital, New Delhi where the consideration of Siddha drug did not appear suppress their enthusiasm.
When Dr.J.R Krishnamoorthy discovered the usefulness of Wrightia tinctoria oil for the treatment of Psoriasis and gifted the same large-heartedly to CCRAS after sharing his invention in joint patent with CCRAS, purely for the benefit of mankind, the dermatologists at RML hospital moved by the gracious gesture of Dr.J.R Krishnamoorhty and has decided to evaluate the efficacy of JRK’s 777 oil on psoriatic patients to reach the science of the same to the world.
As a part of their prior-art search, they found that some sterols present in Wrightia tinctoria have structural similarity with calcipotrial – Vit D3. Calcipotrial is a well-known drug for psoriasis. Therefore, they assumed that the above phytosterols may be exhibiting anti-psoriatic efficacy and hence JRK’s 777 oil is effective. However, they deferred from exploring the cause-and effect mechanism and decided to evaluate the efficacy of JRK’s 777 oil in 26 psoriatic patients by keeping calcipotrial as positive control treatment drug.
Further, to determine the clinical activity accurately, bi-side comparison was planned, meaning two distal end, comparable lesions were chosen and calcipotriol and JRK’s 777 oil were applied separately over the selected lesion. The lesion where JRK’s 777 oil was applied was further exposed to sunlight for 15 minutes for the conversion of phytosterols to calcipotrial.
Although a marginal difference in the clinical efficacy between JRK’s 777 oil and calcipotrial was observed in the lesion, but by week 12, the lesions treated with either JRK’s 777 oil or calcipotrial responded equally. All the key clinical featuresof plaque psoriasis such as redness, thickening and scaling responded well.
JRK’s 777 oil exhibited efficacy which was multi-sectionally comparable with that of calcipotrial proving the discovery of Dr JR Krishnamoorthy stupendous. There are also various other studies done on the Dr.JRK’s 777 oil which proves its efficacy [3- 9].
The compliance behavior of the patients recruited in the present study was very high as most the patients were in the middle age group and wants to achieve treatment success which was possible only through strict compliance of the medication. Irrespective of the duration of the disease, the treatment response was almost the same.
From the above clinical evaluation, we assume that JRK’s 777 oil is very effective for the treatment of psoriasis and the same may be used especially during the early stage of the disease as soon as the disease was diagnosed. Such treatment adoption may help the patients to contain the disease early, prevent drug tolerance, tachyphylaxis and other drug induced problems. JRK’s 777 oil is safe and can be used lifelong. Cost effective and therapeutically promising value also JRK’s 777 oil will offer to the patients.
Findings as established in the clinical situation at RML assume great significance as it gives sufficient scientific evidence to the world that JRK’s 777 oil is very effective for the treatment of psoriasis. The associated safety profile of JRK’s 777 oil should overweight the consideration of JRK’s 777 oil in the treatment of psoriasis than any other medicaments due to the obvious side effects of all those preparations during their prolonged usage.
ACKNOWLEDGEMENT
We acknowledge late Dr. JR Krishnamoorthy, Padmasree awardee who primarily involved in the clinical trial along with the first author.
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