1Anurag  Srivastava, 2Manish  Saxena, 3K.D. Sharma, 4Manish Sharma, 5Amit Goyal, 6Jasbir Kaur

1Professor of Surgery, AIIMS, New Delhi, 3Innovator Neem+ oil, 4Deputy Director (Technical), CCRAS, New Delhi,5Ayurvedic Physician, Senior Resident, AIIMS, 6Assistant Director(Biochemistry), CRIA

This work was being supported by Department of Science and Technology, New Delhi

Introduction
Wounds were probably the first medical problem faced by human race but the knowledge of wounds and their management remained in primitive and stunted stage till recently. Wounds or trauma and the phenomenon of repair are the most common events from birth to life. In Ayurveda the types of wounds and their management has been elaborated in great detail by the pioneer of ancient surgery Sushruta.

Effective management of wounds will become an important challenge in the coming years. In addition surgeons and physicians will be under constant pressure from patients as well as resource providers to give the most cost-effective, high quality wound-care, wherein the quality of life of the patient is minimally disturbed during the period of treatment. Managing the wound and the process of healing is so fundamental that we almost take the process of healing for granted. Most of the wounds will heal with or without treatment. In the midst we suddenly find a patient where there is either major default in the process of healing or good healing process leading to catastrophic functional outcome.

Our knowledge of wound healing is far from complete.  We have applied almost everything we could think of on the wound and still we continue to apply most unphysiological preparations on the wound. Infected wounds in legs, foot and other parts of the body are very common clinical problems that require intensive care in a wound clinic. These wounds are caused by trauma or complicated surgical operations on infected organs. Patients suffering from diabetes, arterial or venous disease of lower limbs have a high risk of developing infected wounds. Any wound / ulcer that does not heal in 6 weeks is said to be a chronic wound.

There is more than one reason why a wound does not heal, infection being just one. Lack of blood supply, venous / arterial insufficiency, radiation, foreign bodies, nutritional deficiency, diabetes, jaundice, alcoholism, local toxins, cancer, steroids and chemotherapeutic agents, hereditary healing disorder, old age etc., can be cited as other reasons. Among these the most common reason being diabetes, where the only solution at times is amputation. These wounds are treated with various antiseptics and dressing materials. Most of these are provided by multinational companies at a very high cost. Moreover the antiseptics used are harmful to the healing and are expensive too.  The high cost makes these unaffordable to the common man. These antiseptics have been actually shown to be cytotoxic and damage the delicate granulation tissue and epithelial cells.

Moreover, these are not available in the villages and interiors of our country as their circulation is restricted. Hence there is a need of an effective indigenous and cheaper remedy. Neem+ oil has been developed to cure chronic and infected wounds. Diabetic ulcers, Bed sores, Venous ulcers, Arterial ulcers and Varicose ulcers. This oil is based on a classical preparation called jatyadi oil. Neem is the major constituent of the oil.

To study the effectiveness of Neem+ oil on chronic and infected wounds, mainly diabetic ulcers and bed sores. A randomized control study has been designed at the All India Institute of Medical Sciences and Central Research Institute for Ayurveda, New Delhi.

Material and Methods
All patients with any variety of wounds viz. Diabetic ulcers, Bed sores, chronic venous ulcer, chronic peripheral arterial ulcers, traumatic wounds and post-op wounds were included in the trial. First of all the wound was cleaned under running tap water for at least 10 minutes to remove all the  dirt/exudates. Patients in the case arm were be asked to cleanse the wound with normal saline followed by calcium alginate dressing impregnated in Neem+ oil which was covered by an absorbent pad and secured with a tape or bandage.  Calcium alginates are extracted from brown sea weed (laminaria hyperboria). Alginate, a polysaccharide, is composed of gluronic and mannuronic acid units linked together. Calcium alginate dressing normally available in the market are : Kaltostat, Curasorb. When this dressing comes in contact with wound exudates it forms a gel which provides a moist environment at the wound site. It is bio degradable, hemostatic absorbent, provides moist wound healing, easy application and removal. It requires dressing changes every 2nd, 3rd and at times upto 5 days, absorbs exudates upto ten times its weight, Controls minor bleeding. Any dead tissue was removed surgically. Patients were asked to come to the clinic after 3 - 4 days or earlier if the dressing gets soaked. In case of heavily exuding wounds the patients was required to come everyday. Patients in the control arm were asked to cleanse the wound with normal saline followed by Calcium Alginate dressing soaked in normal saline and secured with an absorbent pad. Patients were reviewed on each visit and the following details were noted.

Assessment Criteria
Complete healing at the end of 6th week coded as healed/not healed, Amount of discharge from the wound, Pain/Burning/Heaviness in the wound on a visual analogue scale, Time taken for complete healing in days as a continuous variable and Surface area from wound tracing on an acetate sheet.

Results
We randomized 100 patients out of which 50 patients were randomized for case arm and 50 for control arm. Results showed that 45 / 50 patients were completely healed in the case arm whereas 1 / 50 patient completely healed in control arm. In the case arm 27 / 28 diabetic patients were healed compared to none out of 29 patients in control arm. The laboratory parameters were also studied.

Chemical Analysis
Chemical analysis of Neem+ oil was done.  No heavy metal, residual pesticides and steroids were detected.

Antimicrobial Effectiveness
Antimicrobial effectiveness of Neem+ oil, Jatyadi oil and Neem oil were tested on the following organisms E-coli, Pseudomonas aeroginosa, Proteus mirabilis, Staphylococus aureus, Enterobactor aerogenes, Salmonella typhi, Candida albicans. Results showed that Neem oil has remarkably ore antimicrobial effectiveness as compared to Jatyadi oil and Neem oil. The stability test showed that the Neem+ oil is stable even after 3 months at different temperatures: 5°, 25°, 40° and 45°C.

Conclusion
The results of the study have been highly encouraging on diabetic wounds and bed sores.  Neem+ oil would offer a cheaper remedy which is so very critical for a developing nation like India. Any indigenous product as the Neem+ oil will assure the people of a constant supply and low cost