In the era of fast food, there is change or irregularity in diet, diet timings and sedentary life style. In addition to change in diet and life style, one is always under tremendous mental stress. All these causes disturbances in digestive system which results into many diseases amongst them ano-rectal disorder constitute an important group.

Anal fissure is a tear occurring in the anal canal, beginning from the dentate line and extending up to the anal verge.¹ They are characterised symptomatically by pain during or after defecation, anal bleeding and spasm of the anal sphincter. The incidence of anal fissures is about 1 in 350 adults.² Pain is considered to be the most common symptom of anal fissure. One of the reviews taking 876 patients suffering from anal fissure into consideration stated that 90.8% of the patients reported pain as a symptom. Pain reported is sharp and may be present during defecation or even hours after it. Bleeding is another common symptom associated with anal fissures, found in 71% of patients.¹ Many of the patients of acute anal fissures don’t seek medical advice from doctors due to which epidemiology of the disease has not been well estimated.³ Anal fissures are equally seen in both males and females. It is most commonly seen in middle aged and young patients, with the mean age of onset being 39.9 years.¹

The anal fissures have been classified arbitrarily as acute and chronic anal fissures, based on the duration of the presenting symptoms. Patients with symptoms for less than 6 weeks in duration are considered to be suffering from acute anal fissure. The non-operative treatment options for cases of anal fissures are sitz bath, local anaesthetics, topical nitrates, oral intake of fibre, laxatives and topical or oral calcium channel blockers. Sitz bath helps in decreasing the discomfort and pain induced by anal fissures.⁴ The intake of high fibre diet, laxatives like stool softeners and osmotic laxatives have shown to help in the healing of anal fissures.⁵ Use of topical local anaesthetic lignocaine (2%) in the form of gel or ointment is one of the most commonly used mode of treatment for anal fissures.⁶ Patients of chronic anal fissures with long term symptoms may be taken up for surgery which carries an important complication of anal incontinence. Thus, there is a need of new treatment modalities for relief in patients with anal fissure with minimum side-effects.

Parikartika is a condition, not described as a separate entity but is obvious that it is related to the anorectal region with excruciating pain during and after defecation, sometimes associated with bleeding even. It has been mentioned as a complication of other diseases pertaining to the ano-rectal region or a Vyapath of Virechana or Basti Karma⁷. Charaka, Vagbhata, Kashyap and even Sharnagadhar in their Samhitas have dealt with this condition but not in detail. All these Acharyas have commonly included the condition to be an outcome of Virechana and Basti Vyapath. Charaka opines that when Apanavayu gets Avruta by Vyana Vayu then there will be complication like Parikartika, Chardi & etc. While Sushruta has mentioned Guda Parikartika as one of the Poorva Roopa of Arsharoga⁸.

Various scientific studies to substantiate the efficacy of Ayurvedic approaches in the management of fissure-in-ano conducted at different academic and research institutes like  Local application of Jatyadi ghrita, Jatyadi taila, Anu taila, Prabhakara ghrita, Kasisadi Taila, Nimbadi taila, Vranaropana taila, Doorvadi ghrita, Vedanantaka Malahara, different types of Pichu and internal administration of Abhyarishta, Kutajarista, Triphala Churna have proven an edge over the conventional therapies in managing the symptoms viz. pain, bleeding besides healing of ulcer. Adding to this the achievement of bowel regulation is significantly observed in all these studies indicating the uniqueness of Ayurvedic approaches.

A thorough review of scientific study to validate the Ayurvedic approaches in fissure-in-ano revealed that the Guda Varti application has not been given the emphasis. Guda Varti being a modality of drug delivery that certainly enhances the tissue contact time of the drug and improving the bio availability in comparison to conventional local application of drugs. In the similar way suppositories melt and exert local or systemic effects. They are used to deliver both systemically and locally acting medications. So better therapeutic response over the conventional simple local application of drugs and to minimise the local discomfort which is experienced by the Varti this study is selected. In the present study, an effort is made to derive a standard and easily accessible treatment for fissure-in-ano from classical resources. Hence, an effort will be made to modify the formulation into Suppository form and it is selected for the clinical evaluation in the present study in Parikartika (fissure in ano) in comparison with Jatyadi Gritha application.

Objectives of the study

1.  Preparation and standardization Jatyadi Ghrita Suppository.

2. To evaluate the effect of Jatyadi Ghrita application in Parikartika (fissure in ano)

3. To evaluate the effect of Jatyadi Ghrita suppository in Parikartika (fissure in ano)

4. To compare the clinical efficacy in both the groups.

MATERIAL AND METHODS

Study design:

It is a randomized open label comparative clinical study

Sampling technique :

The subjects who fulfil the inclusion criteria and complying with the informed consent (IC) will be selected using random sampling (lottery method) technique.

2. A special case proforma containing all the necessary details pertaining to the study will be prepared.

3. The data obtained in all groups will be recorded, tabulated and statistically analysed.

Source of data:

200 patients of Parikartika (Fissure in ano) will be selected from OPD and IPD of Sri Dharmasthala Manjunatheshwara college of Ayurveda & Hospital, Hassan, for the study.

Method of collection of data:

200 patients who fulfil the inclusive criteria irrespective of gender, religion, economic status will be selected for the study using random sampling technique (lottery method).

Diagnostic criteria:

Classical signs & symptoms of Parikartika (Fissure-in-ano) as mentioned in classical texts.

·       Gudagata Shoola (Painful defecation)

·       Daha (Burning sensation per rectum)

·       Vibandha (Constipation)

·       Gudagata Rakta Srava (Bleeding per rectum)

·       Anorectal examination

Operational definitions/Techniques employed:

Study design:

A minimum of 200 diagnosed subjects of Parikartika( Fissure-in-Ano) will be selected and randomly assigned into 2 groups, namely Standard and Trial comprising of 100 patients each.

 Standard group:

·       Poorva Karma – Complete evacuation of bowel

·       Sukhoshnajala Avagaha Sweda (Sitz Bath) for 20 minutes twice daily.

·       Pradhana Karma – 1gm (2 fingertip units) Jatyadi Ghrita to be applied locally twice daily

·       Paschat Karma - Advise the subject to maintain the hygiene.

·       Tab. Triphala 2-0-2 after food

·       Assessment will be done on BT and at the end of every week of treatment.

·       Follow up: Every fortnightly for a  period of 1 month

 Trial group

·       Poorva Karma- Complete evacuation of bowel.

·       Sukhoshnajala Avagaha Sweda (sitz bath) for 20 minutes twice daily.

·       Pradhana Karma – In lithotomy position subject is advised, to insert well lubricated (with plain Ghrita) Jatyadi kashaya dravya suppository into anal canal, twice daily.

·       Paschat Karma – Advised to lie down in supine position for 5 minutes

·        Advise the subject to maintain the hygiene.

·       Tab Triphala  2-0-2 after food

·       Assessment will be done on BT and at the end of every week of treatment.

·       Follow up: Every fortnightly for a period of 1 month

Total duration of the study: 8 weeks

 4 weeks of intervention or Till the complete healing of fissure whichever is earlier.

4 weeks of follow up once in 15 days.

Assessment criteria:

Assessment of study will be done Before Treatment (BT), After Treatment (AT) and Follow-up (AF) based on the subjective and objective parameters as per case proforma.

Assessment will be done before the commencement of treatment (1^st day), and at the end of every week. Follow up assessment will be done on every fortnightly for the period of 1 month

Assessment of study was done based on following parameters.

 Primary outcome measures :

1. Pain - Vas Scale

2. Bleeding per Rectum

3. Itching – Numerical Rating                        

4.Stool consistency

5.Burning sensation

Secondary outcome measures:

1. Wound  healing

2.Sphincter tone