Clinical Trial of Dilatant Mat Over Emulsion Technology for Instant Pain Relief

Head ache, pain in the neck & back region, cervical region, joint pain etc., are not just agonizing in nature but also would persist for prolonged period of time due to the cause being systemic.¹ such persistent pain would affect not only the quality of life but also the overall productivity of the sufferer. ² 

More often, the management of such pain requires the intervention of a strong non-steroidal analgesic preparations for a prolonged course of time.³  Long term usage of such analgesic preparations known to result in various side effects such acute gastritis, hepatic and renal damage.⁴   The arthritic pain require lifelong medication, where the rotation both the steroidal and non-steroidal drugs are needed. ⁵    Topical pain relieving preparations are although available for the treatment, but their use is limited due to their poor effect and or the relief is short-lived.⁶   The counter irritant (s) based topical formulations in combination with some analgesic drugs like diclofenac or lignocaine have been made to manage the pain through topical route but such formulations found to have limited success in treating pain due to systemic or age or life style associated reasons. ⁷

The topical formulation with variety of active agents having diverse effect to reduce the pain instantaneously is yet to be studied.

Rubefacients, coolants, vasodilatants, tinkling sensation causing substances etc., are largely used in topical pain relieving products.⁸  But still the combination of all such substances in the same formulation need not ensure each individual ingredient to offer their specific benefit and thereby the ‘benefit cascade’ all such substance from the product resulting in instant relief. 

The formulation technology and choice of the base alone can ensure each and every ingredient in the formulation is preserved independently and are made to exert their specific benefit that finally translate to significant relief of pain. 

Akshun ultra gel is a unique formulation where viscoelastic and thermo-physical properties of fluid dynamics has been harmonized.  Two dissimilar viscoelastic fluids one being an emulsion and the other being single phase gelling agent has been combined in the form of a mat over emulsion to hold different active agents with varying degrees of volatility within the same formulation, to offer a variety of counterirritant actions and relieve the pain, instantly. 

MATERIALS AND METHODS

The clinical trial was conducted as per global guidelines involving human volunteers for drug evaluation.  The trial protocol and all other relevant documents needed for trial were approved by Institutional Ethics Committee and the trial was registered in Clinical Trial Registry of India - CTRI No - CTRI/2025/06/089199.  

The clinical trial was aimed to evaluate the pain relieving efficacy of Akshun ultra gel, a topical preparation in relieving the following types of pain of systemic and or life style led origin such as

For the present clinical trial, both direct and indirect parameters were measured where the direct parameters include

1. Extent of relief
2. Time required for perceivable relief
3. Frequency/ number of application needed
4. Duration of relief
5. Initial sensory feel
6. Duration of the sensory feel

The indirect parameter include, the thermal imaging of the skin for Doppler changes before and after the test product application. 

The Doppler change on the skin surface is the indicator of increased vasodilation and associated pain relief.

Demographic details of the patients

50 patients suffering from various types of pain were included in the pain

Patient Enrolment Details

Before                          After

 

 

DISCUSSION

The findings of the clinical trial has clearly shown the remarkable pain relief effect of Akshun ultra gel, a topical formulation adopted with mat over emulsion technology for instant, sustained and complete permeation of the actives. The formulation is made with high proportion of methyl salicylate, menthol, camphor, eucalyptus oil and thymol. The mat tightly hold the high volatile, least emulsifier friendly oils within the skeletal armamentarium of emulsion. This technology allows the greater percentage use of counter irritants and in the formulation and also there rapid and sustain permeation. Since all the above ingredients are highly volatile, soon on contact with skin which is slightly at an elevated temperature during pain can evaporate out than get absorbed into the skin and therefore the formulation may unlikely give the expected relief. In order to achieve greater therapeutic value we have adopted mat over emulsion technology in JRK’s Akshun ultra gel.

50 patients with near equal balance of both gender were involved in the clinical trial. All the patients (male and female) with neck pain, joint pain and low back pain reported complete relief on day 15 of product usage. Further the statistical analysis by paired t test proved the relief to be statistically signification with p value, p < 0.05.

Those who suffered from other types of pain such as musculoskeletal pain, cervical spondylitis and arthritic pain though did not get complete relief but reported noticeable relief by day 30 clearly suggesting that the management of certain pain require also oral medicaments and topical medicaments can only offer transient relief and or may help to reduce the oral drug over load otherwise that may lead to various side effects due to analgesic drugs. The medical conditions that require oral therapy also responded well to Akshun ultra gel though not completely. With the evidence of the patients who reported perceivable relief from pain within 10 minutes clearly suggest the analgesic effect of Akshun ultra gel. Prolonged usage, multiple time usage etc., may offer greater relief where the oral medicament can be reduced.

The sensorial counter irritant responses such as stinging, tingling, cooling and numbing were also perceived by all the patients within 10 minutes of product usage that suggest the possible rapid permeation of a actives into the skin.

In the present clinical investigation we have also analysed the thermal image response in the pain region before and after application of the product by thermal camera.⁹ During pain due to systemic cause, the region would endure muscle spasm/ contraction and compression/cramping of nearby blood vessels, besides vasoconstriction, deep vessel dilation and superficial vessel compression. The above changes bound to alter the blood flow and the same when photographed would appear less reddish.  When an effective topical pain relieving product is applied with ingredients known to offer

1. Vasodilatation
2. Counter irritancy
3. Tingling sensation
4. Cool and numb effect

would naturally increase the blood perfusion and increased vasodilatation. The subsequent imaging would provide deep reddish appearance of the skin clearly indicating the increased blood flow. Our present clinical investigation on all patients (both gender) suffering from different kinds of pain has shown a distinct increase in cherry red appearance in the skin region where they had applied the product relieve the pain. And the difference between the images before and after treatment was obvious and conspicuous. Further all the patients in the group clearly reported complete to significant reduction in pain. In the light of the above finding we confirm the pain relieving mechanism of the product may include vasodilatation and increased blood flow.¹⁰ 

Our comparative evaluation of yet another formulation devoid of mat over emulsion technology but with actives of same proportion did not offer significant pain relief nor any hemodynamic change over skin (data on file).  The clinical trial findings clearly show Akshun ultra gel can instantly relieve various kinds of pains and continuous usage may help to keep the pain at abeyance and also may help in reducing oral medicaments and associated side effects.  

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