A Clinical Study to Evaluate Efficacy of Agnikarma (Locally) and Ashwagandha Ghanavati (Internally ) in the Management of Manyagata Vata w.s.r Cervical Spondylosis

Cervical Spondylosis is described as degenerative condition of the cervical spine. It is found most commonly in individuals aged 40-60 years, leads to symptoms like pain, restricted movement stiffness and tingling-numbness at neck region. In Ayurveda, it can be correlated with Manyagata Vata which is managed with various Panchkarma such as Basti , Raktamokshan ,Nasya, Agnikarma etc. Adjuvant to Vata-Kaphashamak and Asthi Dhatuvardhan palliative drugs . The Agnikarma though effective tool for pain management has varied results due to fluctuation in temperature from intermittent heating of shalaka (metallic probe).To overcome this, conventional Agnikarma device is modified with temperature controlling unit (produces constant temperature) and Raupya Shalaka (specially designed silver probe having micro rods)which helped in minimizing the pain as heat is delivered once at desire site. Adjuvantly, Ashwagandha Ghanavati (internally) was given, which acts as Rasayan to Asthi Dhatu (rejuvenating bone tissue). The combination treatment showed statistically significant results in relieving symptoms such as pain, stiffness, flexion, extension, lateral movement of neck and tingling numbness. Out of 50 patients, 92% patients got complete relief from cervical pain, 98 % patients got relieved from Stiffness whereas restricted movements of neck and tingling numbness present was relieved in 96% patients. The device helps in keeping the temperature constant (60 o C) throughout the procedure & desired heat is delivered by keeping the probe in contact for 10seconds at affected site. In this study, Agnikarma with modified device and AshwagandhaGhanavati revealed their efficacy in relieving symptoms of Manyagatavata . Further, the Agnikarm with modified deviceproved user friendly, safe (without iatrogenic effects) and made procedure swift.


Introduction
Cervical Spondylosis is described as degenerative condition of the cervical spine. Pathology starts at the intervertebral discs and dehydration of discs results in reduction of intervertebral discspace and peripheral osteophytes formation. It is found most commonly in individuals aged 40-60 years. It leads to neck pain, stiffness in the cervical joints, etc. In allopath treatment, palliative medicines requires long term, frequent administration and have untoward effects, hence, there use is limited. Further, in advancement of disease (CSM and Neurological involvement) surgical intervention like laminectomy, decompression, implants etc. are practiced with due risk (1).This gives scope to Ayurveda which has several treatments alternatives for vitiated V ayu in Manyapradesh (neck region).
The description about Manyagata V ata is not available as a separate disease but, mentioned as one of the V atavyadhi in Charak Samhita . As per clinical manifestation, it can be co-related to cervical spondylosis.
Similarly, A gnikarma (intentional heat burn therapy) is also practiced treating A sthigat-Vata induced by vitiated V ata with instant pain management (3).Though, it has been practiced since thousand years, this ancient method of A gnikarma consist of limitations like dependency to poor heat source(flame), intermittent heating of shalaka (heat delivering probe) and fluctuation of temperature and due risk of iatrogenic burns. Hence, to overcome these limitations, conventional A gnikarma device is modified with temperature controlling unit and Raupya Shalaka (specially designed silver probe having micro rods ) which helps in minimizing the pain (as heat is delivered once at desire site). This device helps in keeping the temperature constant (60 o C) throughout the procedure and require single sitting. To deliver the desired heat burn, device is switched on and the probe is kept in contact for 10seconds at affected site.The specially designed kurchak (brush) type of RaupyaShalaka (silverprobe having micro rods) produces Grade 2 burn (Bindu/dot type of Agnikarma) at desire site (4). It produces Samyak-Dagdhavrana rahit Agnikarma (adequate heat burns without scar) and also minimizes risk of iatrogenic burn.
The adjuvant palliative drug A shwagandhapossess properties such asTikta Rasa(bitter taste),Rasayan (rejuvenator) and Balya(nourishing) which helps in controlling degenerative changes and also consist of Cox -2 enzyme which helps in relieving pain and break the pathogenesis (5).
Dosage &Time  Agnikarma-2 sittings of A gnikarma keeping the temperature constant (60 o C) throughout the procedure was given at the interval of 15 days, and probe (shalaka) is kept in contact with skin for duration of 10 seconds at most painful site.  AshwagandhaGhanavati-2 Tablets (of 250mg each) was given twice a day with warm water for 60 days after meals adjuvent to A gnikarma therapy.

Duration (follow up)
Patient was observed for 90 days . However, 2 sittings of A gnikarma at the interval of 15days and adjuvant palliative medicine was given for 60 days only. Simultaneously, the follow up prognosis was recorded in the CRF to draw conclusion.

Criteria for Inclusion
Patients between age group 30 to 60, having clinical features such as pain in cervical region, stiffness, restricted movements of neck and, tingling numbness in upper extremities, irrespective of gender, and X-Ray showing early degenerative changeswere included in the study.

Modified Device of Agnikarma Temperature controlling unit(6)
The temperature controller takes an input from a temperature sensor and has an output that is connected to a control element. It compares the actual temperature to the desired control temperature, or set point, and provides an output to a control element .
This electronic device consists of (i). Electronic Device (ii). The handle which consists of coil (which helps in heating) and specially designed probe (kurchak type specially designed silver probe having multiple small micro rods).
Modified Probe (k urchak type silver pr obe having multiple small micro rods) The specially design Raupya shalaka resembling shape of Trikurchak shashtra (brush) mentioned in Sushrut Samhita had been used for A gnikarma in this study.
Kurchak (brush) type of Raupya shalaka consists of multiple small micro rods of sliver which produces the grade 2 burn at once, instead of multiple burns on different affected site.
This probe has been designed to minimize the pain by applying it on skin for once for mere 10 seconds, utmost tender(painful)part, thus, making the procedure user friendly, safe (without iatrogenic effects) and making procedure swift. (Temper atur e controlling unit with probe)

Image 1: Modified A gnikarm a Device
Vatasamak,Shothhara(anti-inflammatory properties) which are helpful in controlling degenerative changes (7). A shwagandhaalso possess analgesic effect as it consists of cox-2 enzyme that acts on the nervous system to prevent pain signals from being sent.

Method of preparation Collection-
Ashwagandha bharad (crude form) had been purchased from APMC market, Navi Mumbai.

Authentication & Standardization
Drug authentication was done at Mithibai College (botany laboratory) Mumbai and Standardization was done in Alarsin Pharmacy.

Preparation
Ashwagandha bharad of 5kg added with 16times of water and is boiled till the whole contents are reduced to 1/4 th .On cooling it was strained into another vessel.The filtered liquid is placed in a broad based vessel and heated over simmer to moderate flame.Heating was continued till all the moisture was evaporated and only powdered sediment was left alone.Then it was taken out from the fire and preserved in air-tight container.A shwagandha Ghana had been prepared of about 1kg.After this the vati(tablets) weremade by rolling in round mass which is Ashwagandha Ghanavati. (8) It was dried for 2 days after which the standardization test has been done. After standardization test A shwagandha ghanavati is used on patient.

AGNIKARMA PROCEDURE (9)
Purvakarma(Pre-procedure): Patient was made aware of the procedure by explaining them and written/ inform consent was taken from the patient prior treatment. After taking the consent patient is allowed to sit comfortably and the most tender point at cervical region was marked with the marker. Prior starting treatment the Modified Agnikarma device (temperature controlling unit with probe) checked for electric connection and kept ready. Then the desired site where A gnikarma is to be done was properly cleaned with distilled water allowed to dry.

Pradhankarma(Main procedure):
After cleaning the site, the temperature is set on 60 degree Celsius, and then with the help of probe (kurchak type of raupyashalaka)the Agnikarmais performed on most tender site as marked and bindu(dot) type of grade 2heat burn is delivered, till it produces Samyak-Dagdhavrana rahit Agnikarma (adequate heat burns without scar) The shalaka is kept in contact of skin for duration of 10 seconds. This is done only once as the shalaka consist of multiple micro rods to obtain desired effect of A gnikarm.
Image 2:A gnik arm ademonstr ation with Modified Agnikarma Device

Paschat karma (Post procedure):
After the adequate A gnikarma procedure, Yastimadhughrit (medicated clarified butter) was applied at the site of A gnikarma for relieving post burn pain and discomfort. This also promotes healing of post burn wound. As the probe is kept in contact with skin only for 10sec (at 60degree Celsius) post burn scar do not occur. Hence, this procedure can be named as Daghdavrana rahit Agnikarma.

Observation and Result
For this study, the subjective assessment of Dependent variables was done & appropriate statistical test was applied to find out the significance of treatment. The Demographic analysis like age sex etc. is not purview in the present study therefore we have not drawn any conclusion from it.
The demographic analysis on this study r evealed a number of acceptable facts. The age gr oup of maximum patients with cervical region pain was observed between 41 to 50. Cervical spondylosis was observed to be dominant in females (60%) compared to Males. It was dominant in V ata-Kapha (62%), Vata-Pitta (38%). The condition was (64%) prevalent in housewife and 32% in shopkeeper patients.
Subjective parameters ar e taken for the statistical analysis of data in which Wilcoxon Matched pair test was applied.
Out of 50 patients assessing symptomatic relief for 6 parameters viz. Pain, stiffness, flexion, extension, lateral movement and tingling numbness. A gnikarma with modified device (locally)and A shwagandha Ghanavati (internally) proved efficacious in the management of 'ManyagataVata' with 'p' value less than 0.001 showing highly significant. The statistical observations on dependable variables revealed that among 50 patients 92% patients got complete relief from cervical pain, 98 % patients got relieved from Stiffness and restricted movements of neck, Tingling numbness present were relieved in 96% patients(table no.2).

Discussion
Cervical Spondylosis is described as degenerative condition of the cervical spine. It is found most commonly in individuals aged 40-50 years, leads to symptoms like pain, restricted movement stiffness and tingling-numbness at neck region which resembles with ManyagataVata.Inallopath, analgesic, corticosteroid, Muscle relaxants and calcium supplements are prescribed, but with longer time has side effects, soits use is limited. Further, in advancement of disease (CSM and Neurological involvement) surgical intervention like laminectomy, decompression, implants etc. are practiced with due risk (11).
Similarly, Agnikarma is also practiced in Manyagatavata which helps in reducing pain instantly. Hence, the proposed study was primarily aimed to evaluate the efficacy of Agnikarma and Ashwagandha ghanavati in Manyagatavata w.s.r. to cervical spondylosis.
Agnikaram is established and practiced since many years. As Ancient conventional method of Agnikarma consist of limitation like variable heat source (flame, spirit lamp), intermittent multiple heating shalaka which is also time consuming, fluctuation in temperature resulting in inadequate and variable heat delivery and also have due risk of iatrogenic burn which leads in bad prognosis as do not give desire result to patients. Hence, the A gnikarma device is modified which consist of temperature controlling unit with specially designed Raupya shalaka resembling trikurchak shastra.

Image 3: Showing circuit diagram for temperature controlling unit
In this circuit,firstly,AC (Alternating current) current from electric source (standard current of 230volts) always flows in alternating(periodically) direction which drives to transformer (13). Transformer helps in either increasing or decreasing the voltage as required; it helps in transforming the AC current (230 volt) through the electromagnetic field (14) and which further moves to Rectifier. The Rectifier rectifies the current by converting AC current in to DC (direct current) which flows in one direction (15). After Converting from AC to DC it further passes in DC to DC converter. This DC to DC converter is used to decrease the high voltage current to low voltage current as essential for the circuit (16). Thereafter, this current flows to Temperature sensor also acts like thermocouple which entails the two different electrical conductor forming electric junctions at different temperature, it detect the required amount of temperature and directs the temperature(17) to Heater. As the electric current reaches the heater it is changed to heat energy (18). This Heat energy further drives in Micro controller which is made up of processor and Input/output peripherals on a chip ,it controls the input temperature sensed from temperaturesensor and give us the indicator i.e. output (19). In this device handle, specially designed probe is attached to deliver the desired heat to the affected site. This silver probe isTrikurchaktypeofRaupyashalakaconsists of multiple small probes/pins of sliver which produces the grade 2 burn at once, instead of repeated burn. This probe was designed to minimize the pain by applying it on skin for once on tender point.

Probable mode of action
Agnikarma therapy-Mechanism and action of Agnikarma can be understood with the help of afferent spinothalamic tract. In this the ascending neurons are the pathway for conduction of Pain (lateral spinothalalmic tract-Aδ& C Fibres), Pressure (ventral spinothalamic tract -Ruffiniendings), Temperature (lateral spino-thalamic tract). When perception of pressure and temperature factor is increased, pain perception is reduced which helps us to understand the role of A gnikarmain relief of pain. Moreover, another hypothesis suggests that the released heat could have caused irritation on the superficial sensory nerve endings thereby relievingpain from the concept of 'counter irritation'. It has also been suggested that pain may be possibly caused as a result of the accumulation of metabolic waste products in the tissues, and an increased flow of blood (vasodilatation due to heat) in the region is the possible mechanism that is responsible to remove these substances and relieve pain. Another possibility is that the pain releasing mechanism is associated with muscle relaxation (20).
Ashwagandha Ghanavati-Ashwagandha possess properties such as Tikta Rasa(bitter taste),Rasayan (rejuvenator) and Balya (nourishing) which helps in controlling degenerative changes of bony tissue and also consist of Cox-2 enzyme which helps in relieving pain and break the pathogenesis. It's also thought to have some anti-inflammatory properties. For this reason, some research has shown it to be effective in treating arthritis (21).

Conclusion
In this study, the common symptoms of 'Manyagata Vata' like pain, stiffness, restricted neck movements and tingling numbness were relieved with 'Agnikarma (locally done with modified device of Agnikarma) and Ashwagandha ghanavati internally which proved statistically significant.
Out of 50 patients assessing symptomatic relief for 6 parameters like Pain, stiffness, Flexion, extension, lateral movement and tingling numbness for each parameter. Among 50 patients 92% patients got complete relief from cervical pain, 98 % patients got relieved from Stiffness and restricted movements of neck, Tingling numbness present was relieved in 96% patients. Hence, it can be concluded that A gnikarma therapy with adjuvant A shwagandha ghanavati proved highly significant in the management of Manyagata Vata. (table no 3) The modified device for A gnikarma proved user friendly, safe (without iatrogenic effects) and made procedure swift.The interpretation of efficacy and probable mechanism of action of A gnikarma can be explained by combined result i.e. by the action Agnikarma (locally) and Ashwagandhaghanvati (internally).However, it is recommended that the further study should be carried out in large sample size to evaluate and analyze the results. The exact mechanism of action of A gnikarma is to be studied.