Management of diabetic sensory

polyneuropathy with modern extracts

of Ayurvedic herbal medicines – A
double blind randomized controlled trial

Dr. Manish Patel1

Dr. Daniel Scheidbach2; Dr. Mansi Patel1; Dr. Bhumika Patel1;
Dr. Kalapi Patel1; Dr. S N Gupta1
1
J. S. AYURVEDA COLLEGE & P. D. PATEL AYURVEDA HOSPITAL
NADIAD (GUJARAT), INDIA
2
EUROPEAN ACADEMY FOR AYURVEDA, GERMANY
 INTRODUCTION
• Diabetic foot is the biggest cause of lower limb
amputation (60%) and cost in diabetic
populations
(Leone, Pascale, Vitale et al. 2012)

• > 40,000 amputations per year which mainly

caused by Diabetic poly-neuropathy
(Smieja, Hunt, Edelman, & al, 2001)

• In India, > 30% diabetics have polyneuropathy

(Padmaja, Rajiv, Sudhir et al. 2010)
 Introduction contd..
• Therapy of diabetic polyneuropathy have not been
satisfactory addressed till today.

• A traditional herbal (whole drug) combination has

been observed to show extraordinary benefit
(Kalapi, Manish & Gupta 2011);
(Parveen, Gupta & Manish 2017)

• Modern extracts of any herbal medicines are

widely used in present era.
 PURPOSE
➢ To evaluate the effect of modern extract of
Ayurvedic herbal medicines in the patients of
diabetic sensory polyneuropathy versus placebo

• To find out the effect of placebo in diabetic sensory

polyneuropathy
• To find out the effect of modern extract of herbal
medicine versus placebo on signs-symptoms through
NTSS-6 score
• To find out its effect versus placebo on sensations
thresholds through automated Neuropathy Analyser
 METHODS
Study design:
A prospective clinical randomized double blinded placebo-
control trial with 30 patients per group for 3 weeks.

Inclusion criteria:
1. Patients with ≥2 symptoms (one symptom with mod.
severity) in occasional frequency (3 points in NTSS-6)
2. Having moderately impairment of perception of
minimum two sensations from vibration, hot and cold.
3. 20-80 years of age and on stable conventional medication
for diabetes mellitus
 Methods contd..
Exclusion criteria:
Associated clinical conditions influence peripheral nerve
function and patients with clinical co-morbidities
Study Protocol:
- Block (6 block) randomization, 30 patients in each group
- Group (A) treated for 3 weeks with –
1. 2 capsules of 300mg aqueous/alcoholic spray dried
extracts of Sida cordifolia root twice in a day
2. 2 capsules of 300mg extracts of Phyllanthus nirruri thrice
in a day
-Group (B) treated for 3 weeks with placebo of same dose, size
and colored capsules like of group A but filled with 300mg
maltodextrine.
- Continuing conventional anti-hyperglycemic durgs in all the
patients as per their schedule.
 Methods contd..
Outcome measures:
Quantitative sensory testing
(hot, cold and vibration)
through semi-automated
Neuropathy Analyser

Symptoms assessed by Neuropathy Total Symptom Score -

6 (NTSS-6 questionnaire) (Bastyr, Price, Bril, et al. 2005)

Symptom frequency Symptom Intensity

Not Present Mild Moderate Severe
Never or occasional (normal amount) 0.00 0.00 0.00 0.00
Occasional but abnormal (less than 1/3 of
time)
0.00 1.00 2.00 3.00
Often (1/3 to 2/3 of time) 0.00 1.33 2.33 3.33
Almost continuous (more than 2/3 of
time)
0.00 1.66 2.66 3.66
Methods contd..
 RESULTS 1
CHANGES IN PERCEPTIONS OF SENSATIONS IN
25% RIGHT FOOT

20% 19.45% P < 0.01

Treatment Vs Placebo
15%
11.21%
Treatment
10%
group
Placebo
5% group
2.83%
0.72%
0%
-0.65% -2.05%
Vibration Hot Cold
-5%
 RESULTS 2
CHANGES IN PERCEPTIONS OF SENSATIONS IN
LEFT FOOT
25%
P < 0.01
20.02% Treatment Vs Placebo
20%
17.67%

15%

Treatment
10%
group
4.96% Placebo
5% group
0.12%
0%
-1.05% -1.18%
Vibration Hot Cold
-5%
 RESULTS 3
IMPROVEMENT IN SIGNS AND SYMPTOMS

P < 0.05
40% Treatment Vs Placebo
35.7% 35.3%
35% 32.6% 33.6%

30% 28.2%
Treatment
25%
group
20% Placebo
15% group
10% 9.3%
7.3% 7.1% 6.1%
5% 3.9%

0%
Aching Allodynia Burning Numbness Prickling
 RESULTS 4

• Laboratory parameters related to liver and renal

functions found within normal limits in both the
groups

• PP2BS significantly decreased (never gone under the

100 mg%) in group A and remain unchanged in
group B

• No any adverse reactions found in both the groups

 CONCLUSION
• Herbal extract significantly improve the perceptions
of vibrations, hot and cold sensations

• Significant reduction of the signs and symptoms were

found in treatment group in compare to placebo

• The improvement may be due to the disease

modifying effect of given treatment by means of its
mehaghna, rasāyana and anti vāta-pitta actions.

• Studied herbal extract was safe and effective and its

long term use will may be more effective.
 BIBILOGRAPHY 1
• Bastyr, E., Price, K. et al. (2005). Development and validity testing
of the neuropathy total symptom score-6: questionnaire for the
study of sensory symptoms of diabetic peripheral neuropathy.
Clinical Therapeutics, 27(8): S 1278-94.

• Kalapi Patel, Manish Patel, S N Gupta (2011). Effect of

Atibalamoola kvatha and Bhumyamalaki churna on thirty-three
patients of diabetic sensory neuropathy. AYU 32(3): 353-56

• Leone, Pascale, Vitale, & al, e. (2012). Epidemiology of diabetic

foot. Infez Med, S. 8-13

• Parveen Yadav, Manish Patel, S N Gupta (2017). A case of

Diabetic sensory polynuropathy successfully managed with
Atibalamoola kvatha. Int J Ayu Pharm Chem 6(3): 253-56
 BIBILOGRAPHY 2
• Padmaja, K. R., Rajiv, R., Sudhir, R. R. et al. (2010). Prevalence
and risk factors for severity of diabetic neuropathy in type 2
diabetes mellitus. Indian Journal of Medical Sciences, 64 (2): 51-
57.

• Smieja, M., Hunt, D. L., Edelman, D. et al (2001). Clinical

Examination for the Detection of Protective Sensation in the Feet
of Diabetic Patients. Journal of General Internal Medicine,
14(7):418-424.
 ACKNOWLEDGEMENTS
• Authors are thankful to REAA- Germany for
sponsoring the project and Prof. Matin Mittwede,
Prof. Uhleke Bernhard for their valuable suggestions.

• Thankful to Sears Phytochem, Indore, Dravyaguna &

RS-BK dept of J S Ayurveda College for
authentication and manufacturing of study medicines

• Thankful to Pharmacy College of D D University for

analysis of study medicines

• Conflict of interest : Nil