International Journal of Science and Research (IJSR), India Online ISSN: 2319-7064
Volume 2 Issue 8, August 2013
www.ijsr.net
A Clinical research of Siddha Drug “GLY CYN
NEU” Ointment for AzhalVaatham (Neuropathy)
S. R. Pholtan Rajeev1, U. D. S. Sewwandi2
1 BSMS (Hons), University of Jaffna
Intern Medical Officer, Department of Ayurveda, Sri Lanka
2 BAMS, Dip in Ayurveda, M.phil (University of Colombo), Medical Officer (Research)
BMARI, Nawinna, Sri Lanka
Abstract: As a huge medical system in the World, herbal drugs are very effective for many diseases. However Diabetes Mellitus also
control by herbal drugs even though not efficiency reducing the symptoms of Neuropathy. Therefore this research tries to correct that
problem by poly herbal formula. In commonly patients are suffering from peripheral neuropathy caused by Diabetes Mellitus. We would
like to do research in efficacy of ARUGANKATTAI PASTE (GLY CYN NEU Ointment) and Control Drug (placebo). Case control
double blind clinical study measured to assess the effect of the treatment by significant relief of burning sensation within a month. The
neuropathic symptoms; very mild grade 46.15% in Group-I (D.M.T), Marked improvement grade 15.38%, Moderate improvement grade
38.46% in Group-II (GlyCynNeu Ointment) and mild improvement 23.08%, very mild improvement 07.69% in Group-III in burning
sensation than the Numbness, Numbness & Burning sensation (both).In statistically way, this research is qualitative analyses therefore
compare with two and analyzed significant of each compares. However final identical results say: Comparing the control (Group-I),
GlyCynNeuointment (Group-II) was shown Significant (p<0.05) reduction in symptoms of neuropathy. GlyCynNeu Ointment was
significantly (p<0.05) change symptoms of neuropathy within one month (4th Week) of treatment. Finally, concluded effectiveness of
research drugs GLY CYN NEU Ointment significant most effective than Control Drug Group-III and Hospital Diabetic treatment
(Group-I) for Diabetic Neuropathic symptoms. In neuropathic symptoms, BURNING SENSATION was highly notified changes like
reducing within one a month than other symptoms.
Keywords: AzhalVaatham (Siddha Medical term), Neuropathy, Diabetes Mellitus (D.M), GlycyrrhizaglabraLinn, Cynodondactylon Linn.
1. Introduction
1.1 Background
Peripheral neuropathy is the term for damage to nerves of
the peripheral nervous system which may be caused either
by diseases or trauma to the nerve or the side-effects of
systemic illness. The four cardinal patterns of peripheral
neuropathy are polyneuropathy, mono-neuropathy, mononeuritismultiplexand
autonomic neuropathy. The most
common form is (symmetrical) peripheral polyneuropathy,
which mainly affects the feet and legs.[6.1]This is known as
AzhalVaatham in Siddha system of Medicine.[5]
Pathologically, diabetic neuropathy is a segmental
degeneration of the peripheral nerve. Clinically, the
condition is heralded by the onset of paraesthesia of limbs,
fingers and toes; burning sensation of hands and feet;
cramps and pains in the legs and muscles. [6.1]
In commonly patients are suffering from peripheral
neuropathy caused by diabetes mellitus.[6.1] We would like
to do research in efficacy of ARUGANKATTAI PASTE[1] ,
[2](GLY CYN NEU Ointment) and placebo. Case control
clinical study measured to assess the effect of the treatment
by significant relief of burning sensation within a month.
1.2 Research Problem
As a huge medical system, herbal drugs are very effective
for many diseases. However Diabetes Mellitus also control
by herbal drugs even though not efficiency reducing the
symptoms of Neuropathy. Therefore this research tries to
correct that problem by poly herbal formula. This drug may
more valuable product to the new generation.
1.3 Objectives
1.3.1 General Objective
To relief the Symptoms of Neuropathy in diabetic patients
and give healthy life style.
1.3.2 Specific Objectives
To introduce a new Siddha drug for Diabetic
Neuropathy.
To give a new look for herbal formula for Diabetic
Neuropathy patient.
1.4 Hypothesis
The drug ARUKANKATTAI Paste – “GlyCynNeu
Ointment” can reduce the Diabetic Neuropathic symptoms
of hands & legs.
2. Materials and Methods (Methodology)
Type of Research: Double blind Case Control -Clinical
Study.
Research area: Bandaranaike Memorial Ayurvedic Research
Institute. (BMARI)
Research period: 02 months
Research Samples: 45 patients
29
International Journal of Science and Research (IJSR), India Online ISSN: 2319-7064
Volume 2 Issue 8, August 2013
www.ijsr.net
2.1 Identification of Diabetic Neuropathy patients
according to clinically diagnosis.
Parameters Measured: The parameters measured were both
objective and subjective.
Subjective parameters included pain; burning sensation;
numbness.
Objective parameters included assessment of pain
appreciation- pinprick; assessment of light touch in upper
and lower limbs; assessment of position sense; reflexes;
trophic changes; shininess of the skin; ulcers; ability to
walk; hyperhidrosis; blood pressure; urine analysis; and
fasting blood sugars.
2.1.1 Inclusive Criteria
Patients were eligible if they were 18–65 years of age, had
type 2 diabetes according to the known diabetic patients by
past diagnostic medical report, were treated with diet, oral
anti-diabetic agents and/or insulin, had stable glycemic
control according to the investigator’s judgment over 3
months before entry into the study, and had evidence of
symptomatic symmetrical or Asymmetrical distal
neuropathy.
2.1.2 Exclusive Criteria
Were the following:
1. Asymmetrical neuropathy of the trunk and proximal
lower limbs,
2. Presence of foot ulcers,
3. Peripheral vascular disease (non-palpable foot pulses,
intermittent claudication),
4. Myopathy,
5. Causes of neuropathy. Other than diabetes and significant
neurological diseases,
6. Participation in a study of any investigational drug for
neuropathy within the 3 months before the study,
7. Use of antioxidants or vitamin B within 1 month before
the study,
8. Severe concomitant diseases, and
9. Pregnancy, lactation, or childbearing age without birth
control devices.
3. Literature Review
2.1-Disease Review [6.1]
2.1.1 Siddha view of AzhalVaatham (Neuropathy)[5]
2.1.2 Modern view of Neuropathy [6.1]
2.2-Drug Review
2.2.1 GlycyrrhizaglabraLinn [3]
2.2.2 CynodondactylonLinn [3]
2.2.3 Coconut oil [3]
2.2.4 Bee’s Wax [4]
1) Identify the treatment in Siddha Pharmacopoeia.
2) Making for sample and check the quality for phytochemicals
and standardization.
3) Making the final product of the Siddha drug.
4) Clinical test for the drug from 45 patients in OPD (Out
Patient Department) and wards and data collecting from a
suitable Proforma.
5) Assessment Criteria
3.1 Final Assessment Criteria
I. High Marked. (not cured)
II. Marked improvement.
III. Moderate improvement.
IV. Mild improvement.
V. Very mild.
VI. Not improvement.
VII. Aggressive.
6) Analysis of the data and making the thesis.
Qualitative Statistical analysis.
3.2 Drug preparation
We had prepared Research drug and control drug which as
placebo.
3.2.1 Research drug
Ingredients:
Arugampul Cynodandactylon 20kg
Atimaduram Glycyrrhizaglabra 100g
Coconut Oil Cocosnucifera 2.5 bottle
Bee’s Wax required amount.[1], [2]
Method of preparation
Pounded the Arugampul and took the juice. Added equal
amount of oil into the juice and boiled them. At the boiling
time put the Atimaduram powder into the oil. After that
boiling oil container and took off from the fire. Filtered and
added the Bee’s wax into the oil which as an ointment stage.
[1], [2]
Finally warm oil filled into the one ounce small plastic
containers in equal amount (30ml). After that kept 30
minutes for become cool ointment. [1], [2]
3.2.2 Control drug
Ingredients:
Coconut Oil Cocosnucifera 2.5 bottles
Bee’s Wax required amount.[4]
Method of preparation:
Put the Coconut oil into the vessel and heated. At the boiling
time put the Bee’s wax into the oil which as an ointment
stage. Finally warm oil filled into the one ounce small
plastic containers in equal amount (30ml). After that kept 30
minutes for become cool ointment. [4]Research and control
drug final products are everything is similar (Labeling also)
and non-identical.
3.3 Clinical Study
Clinical trial had done for research drug and Placeboto45
patients in OPD (Out Patient Department) and wards. Data
were collecting from a suitable Proforma.
30
International Journal of Science and Research (IJSR), India Online ISSN: 2319-7064
Volume 2 Issue 8, August 2013
www.ijsr.net
Grouping the Samples:
In this research, total sample divided into three (03) groups
but all are same symptomatically Diabetic neuropathy
condition. Those three groups are given below,
Group I: Diabetic neuropathy patients with Hospital
internal treatment (DMT).(15 patients)
Group II: Diabetic neuropathy patients with Hospital
internal treatment (DMT) and Research Drug
(GlyCynNeu Ointment) external treatment.(15
patients)
Group III: Diabetic neuropathy patients with Hospital
internal treatment (DMT) And Control drug
treatment.(15 patients)
Hospital D.M.T is as follows:
Medicine Dosage Period of
intake Vehicle (Anupana)
ThiripalaQwatha 30 ml Twice a day -
ThiripalaChoorna 30 grains Twice a day With warm water
Somanatha Rasa 02 Tablets Twice a day juice of bitter gourd
In our research Group-I, II & III:
Initial - 15 samples
Dis continue samples- 02 samples
End of the research – only 13 samples
4. Result and Discussion
Phyto-Chemical analysis Report of the Research Drug
Organoleptic Characteristics:
Colour – Green
Odour – Coconut Oil smell.
Taste – Sweet
Physico-Chemical Specifications:
Specific gravity – 0.9200
Loss on drying – 0.07%
Acid Value – 1.24
Saponification value – 274.22
Reported from:Research& Quality Assurance Laboratory,
BMARI, Nawinna.
Each sample progress chart in every Week
4.1 Final Assessment of hospital D.M treatment on the
clinical symptoms of Diabetic Neuropathy (Group I)
End of the research (after 04 Weeks) effect of the Group- I;
burning sensation in very mild level and only 06 samples,
numbness in very mild level – 03, not improvement-01and
Burning sensation & Numbness in Very mild-01 sample, not
improvement-02 samples.
End of the research (after 04 Weeks) effect of the Group- I;
burning sensation in very mild level and only 46.15%,
numbness in very mild level – 23.08%, not improvement-
07.69% and Burning sensation & Numbness in Very mild-
07.69%, not improvement-15.38%.
4.2 Final Assessment of “GlyCynNeu” Ointment
treatment on the clinical symptoms of Diabetic
Neuropathy (Group II)
End of the research (after 04 Weeks) effect of the Group- II,
burning sensation in marked improvement – 15.38% ,and
moderate improvement – 38.46%, numbness in marked
improvement– 07.69%, moderate improvement-15.38% and
Burning sensation & Numbness in marked improvement-
07.69%, moderate improvement-15.38%.
4.3 Final Assessment of Drug Group-III treatment on the
clinical symptoms of Diabetic Neuropathy (Group III)
End of the research (after 04 Weeks) effect of the Group- III,
burning sensation in mild level-23.08% and very mild
improvement 07.69%, numbness in mild level – 23.08%,
very mild improvement-38.46% and Burning sensation &
Numbness in mild level-07.69%.
5. Charts in Data Analyzing
5.1 Progress of the symptoms with treatment of sample
group I, II& III:
1-High Marked.(but not cure)
2-Marked improvement.
3-Moderate improvement.
4-Mild improvement.
5-Very mild.
6-Not improveent.
Final Assessments
and Analogue Score
31
International Journal of Science and Research (IJSR), India Online ISSN: 2319-7064
Volume 2 Issue 8, August 2013
www.ijsr.net
Progress of the Neuropathic Symptoms with research drug
and controls in 04 weeks in Sample Group-I (initial visit, 1st
week, 2nd Week, 3rd Week and 4th Week).
Progress of the Neuropathic Symptoms with research drug
and controls in 04 weeks in Sample Group-II (initial visit, 1st
week, 2nd Week, 3rd Week and 4th Week)
Progress of the Neuropathic Symptoms with research drug
and controls in 04 weeks in Sample Group-III (initial visit,
1st week, 2nd Week, 3rd Week and 4th Week)
5.2 Statistical Analysis
This research can analysis with QUALITATIVE
STATISTICAL ANALYSIS not quantitative analysis
therefore we analyzed symptoms in grading level not
measurable therefore we used in qualitative way. We used
Minitab 14 as statistical package. In a qualitative test or
research Wilcoxon rank sum test (Mann-Whitney Test) is
used to compare two independent samples.[6.2]
6. Neuropathic Symptoms
6.1 Group-I & Group-II 4th Week (AFTER treatment)
level of the samples.
The test is significant at 0.0001 (adjusted for ties)
Comparing the control (Group-I), GlyCynNeu Ointment
(Group-II) was shown Significant (p<0.05) reduction in
symptoms of neuropathy.
One month (4th Week) of treatment with GlyCynNeu
Ointment significantly (p<0.05) change symptoms of
neuropathy with the control group (group-I).
6.2 Group-I & Group-III End of the research (4th Week
level) of the samples.
The test is significant at 0.0602 (adjusted for ties)
Comparing the control (Group-I), Drug Group-III(Group-
II)was shown not Significant (p>0.05) reduction in
symptoms of neuropathy.
One month (4th Week) of treatment with Drug Group-III
not significantly (p>0.05) change symptoms of
neuropathy with the control group (group-I).
6.3 Group-II& Group-III End of the research (4th Week
level) of the samples.
The test is significant at 0.0018 (adjusted for ties)
Comparing the control (Group-I), GlyCynNeuOintment
(Group-III) was shown Significant (p<0.05) reduction in
symptoms of neuropathy.
One month (4th Week) of treatment with GlyCynNeu
Ointment significantly (p<0.05) change symptoms of
neuropathy with the control group (group-III).
7. Burning Sensation
Group-I & Group-II End of the research (4th Week level) of
the samples. The test is significant at 0.0012 (adjusted for
ties)
Comparing the control (Group-I), GlyCynNeuOintment
(Group-II) was shown Significant (p<0.05) reduction in
burning sensation.
One month (4th Week) of treatment with GlyCynNeu
Ointment significantly (p<0.05) change symptoms of
neuropathy with the control group (group-I).
8. Discussion and Conclusion
This research is clinical control study and also double blind
clinical assessment and qualitative analysis research.
Selection of samples and same time preparation of our new
research drug is initial works. There after data collections
and observation of the progress of the effect of the research
drug. Finally was analyzed by the tables, charts and
statistical way. According to tables, charts and statistical
result; Each every table explained various angle of collection
of the data and observations with sum of numbers and
percentage level. In final analysis, according to the
neuropathic symptoms; burning sensation- very mild grade
46.15% in Group-I (D.M.T), Marked improvement grade
15.38%, Moderate improvement grade 38.46% in Group-II
(GlyCynNeu Ointment) and mild improvement 23.08%,
very mild improvement 07.69% in Group-III than the
Numbness, Numbness & Burning sensation.
Charts were used two types because Bar charts are using for
analysis with initial stage to end stage and Pie charts were
used to indicate percentage clearly. In statistically way, this
research is qualitative analyses therefore compare with two
and analyzed significant of each compares. However finally
we got identical result.
In statistical results say, Comparing the control (Group-
I), GlyCynNeu Ointment (Group-II)was shown
Significant (p<0.05) reduction in symptoms of
neuropathy.
GlyCynNeu Ointment was significantly (p<0.05) change
symptoms of neuropathy within one month (4th Week) of
treatment.
32
International Journal of Science and Research (IJSR), India Online ISSN: 2319-7064
Volume 2 Issue 8, August 2013
www.ijsr.net
Finally, we concluded effectiveness of our research drugs
GLY CYN NEU Ointment most effective than Drug
Group-III and Hospital Diabetic treatment (Group-I) for
Diabetic Neuropathic symptoms. In neuropathic
symptoms, BURNING SENSATION was highly notified
changes like reducing within one a month than other
symptoms.
Reference
[1] Ramanathan.P, MD(s), ‘Siddha Pharmacopoeia’, All Sri
Lankan Siddha Ayurveda Medical Officers’ Union, Sri
Lanka, 1st Edition-2000, page No: 102.
[2] Narayanaswami.V, HPIM, ‘Pharmacopoeia of Hospital
of Indian Medicine – SIDDHA’, Tamil Nadu Siddha
Medical Board, Madras-600 106, 2nd Edition-1995,
Page No: 29.
[3] Murugesamuthaliyar.K.S, “Gunapadam-
Mooligaithokuppu” (1st Part), University of Indian
Medicine, Madras- 600 106, 3nd Edition- 1936, page
no:09, 10, 36, 37,383, 384, 385, 386.
[4] Thiyagarajan.R, L.I.M, “Gunapadam-
ThadhuJeevaVakuppu” (2nd& 3rd Part), Indian
Medicine, Department of Homeopathy, Madras- 600
106, 2nd Edition, 2003, page no: 743.
[5] Ponnaiyah.I,“Sekarasasekaravaiththiyam” Provincial
Department of Indigenous Medicine, North-East
Province, Sri Lanka, 2000, page no: 115, 116, 217.
[6] Electronic References:
1. Internet:
a. www.wekipedia
2. Statistical software
a. Minitab.
Author Profile
Dr. S. R. Pholtan Rajeev received the B.S.M.S.
(Bachelor of Siddha Medicine and Surgery) degree
with Class in medical field from University of Jaffna
in 2011 and completed internship training registration
at SLAMC in 2012, respectively. During internship
period, he had done clinical research in Bandaraneika Memorial
Ayurvedic Research Institute (BMARI), Sri Lanka. He already
published student research works in monographs of Medicinal
plants in under graduate period.
33
