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Introduction

Shalya-Chikitsa, a well-developed branch of Ayurveda, predominantly deals with the anorectal surgeries.Description of Parikartika described in Brihat-trayi is very much suggestive of the modern ailment fissure-in- ano when it is limited to anal-region. It is one of the most upsetting disorders of the Ano-rectal region. Chronic anal fissure needs surgical intervention in form of fissurectomy, which is considered to be the gold standard method of management of chronic fissure[1]. Post-operative wound care of fissurectomy varies fromany other surgical wounds due to various reasons. These wound causes post-operative pain, burning & irritation at anal region. The wound, being at the delicate place, makes it inconvenient to patients to perform their routine activities. Defecation causes irritation, severe pain along with burning sensation. Faecal material contaminates the wound further. Unlike wounds on other places, the dressing of these wounds needs to be changed frequently. For better outcomes, the fissurectomy wound needs care unlike other wounds as mentioned above.

The goal for post- operative pain management is to reduce or eliminate pain and discomfort with nominal or no side effects. To overcome this severe pain in the post-operative phase, the surgeons prefer opioids and NSAIDs. Both these opioids and NSAIDs have got adverse effects like respiratory depression, vomiting, drug dependency etc. Prolonged administration of NSAIDs may suppress the symptom but causes gastric irritation. Application of soothing ointments produces sufficient relaxation of sphincter, but causes toxicity and headache and recurrence rate is16% to 50% in this particular method of management[2].

There is need of soothing ointment which can reduce irritation, relieve pain & promote wound healing. In Dravya Sangrahaniya Adhyaya of Sushrut Samhita, Acharya Sushrut explains Gana which deals with the general classification of drugs according to their therapeutically properties. This gana can be use in single dravya or group of dravyas for specific disease.

Acharya Sushrutahas explained theSarivadi Gana in Dravya Sangrahaniya Adhyaya which includes Sariva, Madahuka, Chandana, Kuchandana, Padmaka, Kashamari (Gambhari) phala, Madhuka-Pushpa and Ushira. Acharya Sushruta considered it as Visheshad Dahanashana therapeutically[3]. The single Dravya or group of Dravya from a Gana can be used for treatment of specific disease.

Gambhari Phala was chosen for the following reasons[4]

1. Guna - Guru, Tikta-Kasaya-Madhura Rasa, Tridosha shamaka, Daha prasamana, Snehana and Raktapittaghna.

2. Easy availability.

3. Cost effective.

4. Devoid of complications.

In the present case series, Gambhari Phala was used in the form of gel which is easier to apply compared to Churna, Kashaya, Taila or Ghrita. Gambhari Phala gel was used as Lepana for healing purpose in post fissurectomy wound. The primary objective was to study the effect of Gambhari Phala gel in the management of post fissurectomy wound healing.

Aim: To evaluate the effect of Gambhari Phala gel in the management of post fissurectomy wound healing.

Materials and methods:

Source of data

• Literary Source: The source of parikartika and fissure-in-ano is collected from the various classical texts of ayurveda & modern science, updated with journals and internet.

• Clinical Source:The present comparative case series was conducted at OPD and IPD of Dept. of Shalyatantra Dr.G.D.Pol Foundation’s Y.M.T. Ayurved Medical College and Hospital, Kharghar, Navi Mumbai.

• c) Drugs: The trial drug “Gambhari Phala” is collected from the local area and certified by the Alarsin Ayurvedic Drugs Company.

Methods of preparation

Here kwatha is the liquid preparation obtained by boiling 1 part of dravya in along with 16 parts of distilled water which is reduced to 1/8 th part and filtered, the filtrate is taken as kwatha.

prepared 1000ml of Gambhari Phala Kwath was taken in to the planetary mixer of 2 L capacity having maximum speed of 3000 rpm and stirring was started. In vessel 2% of Carbomer (20gm) was added subsequently. The mixture was stirred at speed of 300 rpm for initial 15 minute gradually increased after every 5 minutes. after 2 hours of continuous staring, a homogenous mixture was obtained, stirring was stopped and 1% of methyl paraben 2gm and propyl paraben 0.5 gm was added and trietatahnoalamine1.65% (165ml) was added and again stirred at 3000 rpm for 5 minutes. Then gel filled in empty sterile container.

Method Of Collection of Data:

Selection Of the study participants: Patients of either sex diagnosed to have fissure-in-ano and operated for fissurectomy were selected randomly. Immuno-compromised patients, patients with Secondary Infected wound and Uncontrolled Diabetes mellitus were excluded from the study.

A detailed Case Record Form (CRF) was prepared considering all the points pertaining to history, signs, symptoms & examinations as mentioned in classical Ayurvedic texts & allied sciences to confirm the diagnosis.

Study Design:

Allocation of subjects: 10 patients were selected for the study who fulfilled the inclusion criteria. The subjects were randomly divided into two groups with 05 subjects in each group.

1. Trial Group: 05 patients enrolled in this group; the wound was cleaned with normal saline & dressed with Gamhbari Phala gel.
2. Control Group: 05 patients enrolled in this group; the wound was cleaned with normal saline & dressed with betadine ointment.

Duration of Study: Total duration of study was 21 days or till the Daha and Vedana persist. Regular Follow ups were taken on done on 0,7,14 and 21 days.

Criteria of Assessment: The patients' responses were assessed on the basis of following parameters:

1. Pain[7] - its intensity was recorded and graded as per the pro forma. Tools for pain assessment used were PAIN (Numerical rating scale) (NRS) and PAIN (Verbal rating scale) (VRS) – on 0 to 3 scale
2. Burning sensation (Daha)[8]– on 0 to 3 scale
3. Granulation– on 0 to 3 scale
4. Discharge – present or absent

Plan for Statistical Analysis:

The study data generated and collected was put to statistical analysis to reach to the final results and conclusions.Appropriate parametric or non-parametric tests were applied to data. GraphPad In Stat Version 4.0 (www.graphpad.com) software was used for statistical analysis of data. P value < 0.05 was considered statistically significant.

Results:

The average age of patients in trial and control groups were 34.20 ± 5.31 years and 39.60 ± 11.68 years respectively with statistically insignificant difference.

It was observed that Pain got reduced to significant level after treatment in both groups. The inter-group difference was found to be insignificant on all follow up visits. Burning sensation (Daha) also got reduced to significant level after treatment in both groups. The inter-group difference was found to be insignificant on all follow up visits. Granulation was found to be significant in both the groups. Discharge from the post operative wound was observed in one patient in the Trial Group and two patients in the Control Group on Day 0. No discharge was observed on Day 14 and Day 21 in any patients from both the groups. No inference can be drawn from this data. It is found that the difference in all efficacy parameters in two groups were statistically insignificant. The days requited for wound healing in trial and control groups were 21.20 ± 2.78 days and 24.60 ± 2.07 days respectively with statistical insignificant difference. No adverse events were observed in both the groups during study duration.

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Discussion

Fissure-in-ano is the ailment that does not have any direct correlation in the Ayurvedic text. ‘Parikartika’ is a condition occurring due to improper administration of Virechana and Basti can be compared with fissure-in- ano, since both the conditions occur in Guda and have similar clinical manifestations. Since the location, nature of pathology and the predominant clinical feature are same, it can be said that the condition Parikartika is the clinical condition known in current surgical practice as fissure in ano. Vata and Pitta Do?ha have dominancy in the development of the disease Parikartika, but Vata is predominant. Sedentary life style and hard work and stressful life like businessmen, in the modern era, is having a key role in occurrence of the disease Parikartika (fissure-in-ano).Fissure-in-ano was present commonly at 6 o’clock position and most of the time it is a single fissure only. However, the fissure at 12 o’clock or at other site may also be found either alone or in combination. Excessive consumption of Lava?a, Katu, Tikta, Ruk?ha, U?h?a, Lagu ahara and irregular diet and diet timings are the main precipitating factors of this condition.In this study Gambhari Phala gel was selected to evaluate its role in the post fissurectomy wound healing of Parikartika because it has Vrana Ropana, Shothahara, Var?a Prasadana, Rakta Stambhana in actions.The treatment with Gambhari Phala gel and betadine ointment in each follow up showed good efficacy in respective trial and control groups. There was statistically insignificant difference in inter-group comparison which showed that Gambhari Phala gel is comparable to Betadine ointment in post fissurectomy wound healing.

Some dravyas act by rasa, some by their Virya, some by their Guna, some by their Prabhava, when rasa etc are of equal strength then, rasa is over powered by vipaka, both these are over powered by Virya, all these are over powered by Prabhava, this is verily the way of natural strength. Gambhari Phala has Tikta, Kashaya and Madhura Rasa, Ushna Veeya and Katu Vipaka. Because of its Rasa and Veerya, it worked as Vrana-Ropana and Shothahara. The gel form made it easier for application and thus led to good compliance.

Conclusion

On clinical and statistical analysis, it was found that dressing with Gamhbari Phala geland conventional method (betadine ointment) has shown equally effective in Pain (VRS), Pain (NRS), Burning sensation (Daha), Granulation and wound Discharge in post fissurectomy wound care. Hence, patient who are allergic  to betadine ointment we can use Gamhbari Phala gel in post fissurectomy wound.

Suggestion:

As chronic conditions may need long term therapy for achieving better results and to avoid reoccurrence so, in future same topic should be taken for further research to overcome some lacunas if found, for better results a greater number of samples.