Effect of jatyadi gritha application and jatyadi kashaya dravya suppository in parikartika(fissure in ano) randomized comparative clinical study

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 lifestyle, one is always under tremendous mental stress. All these causes disturbancesin digestive system which results into many diseases amongst them ano-rectaldisorder constitute an important group.

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

The anal fissures havebeen classified arbitrarily as acute and chronic anal fissures, based on theduration of the presenting symptoms. Patients with symptoms for less than 6weeks in duration are considered to be suffering from acute anal fissure. Thenon-operative treatment options for cases of anal fissures are sitz bath, localanaesthetics, topical nitrates, oral intake of fibre, laxatives and topical ororal calcium channel blockers. Sitz bath helps in decreasing the discomfort andpain induced by anal fissures.4 The intake of high fibre diet,laxatives like stool softeners and osmotic laxatives have shown to help in thehealing of anal fissures.5 Use of topical local anaestheticlignocaine (2%) in the form of gel or ointment is one of the most commonly usedmode of treatment for anal fissures.6 Patients of chronic analfissures with long term symptoms may be taken up for surgery which carries animportant complication of anal incontinence. Thus, there is a need of newtreatment modalities for relief in patients with anal fissure with minimumside-effects.

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

Various scientific studies to substantiate the efficacy ofAyurvedic approaches in the management of fissure-in-ano conducted at differentacademic and research institutes like Local application of Jatyadi ghrita, Jatyadi taila, Anu taila,Prabhakara ghrita, Kasisadi Taila, Nimbadi taila, Vranaropana taila, Doorvadighrita, Vedanantaka Malahara, different types of Pichu and internaladministration of Abhyarishta, Kutajarista, Triphala Churna have proven an edgeover the conventional therapies in managing the symptoms viz. pain, bleedingbesides healing of ulcer. Adding to this the achievement of bowel regulation issignificantly observed in all these studies indicating the uniqueness ofAyurvedic approaches.

A thorough review of scientific study to validate the Ayurvedicapproaches in fissure-in-ano revealed that the Guda Varti application has notbeen given the emphasis. Guda Varti being a modality of drug delivery thatcertainly enhances the tissue contact time of the drug and improving the bioavailability in comparison to conventional local application of drugs. In thesimilar way suppositories melt and exert local or systemic effects. They areused to deliver both systemically and locally acting medications. So bettertherapeutic response over the conventional simple local application of drugsand to minimise the local discomfort which is experienced by the Varti thisstudy is selected. In the present study, an effort is made to derive a standardand easily accessible treatment for fissure-in-ano from classical resources.Hence, an effort will be made to modify the formulation into Suppository formand it is selected for the clinical evaluation in the present study inParikartika (fissure in ano) in comparison with Jatyadi Gritha application.

 Objectives of the study

1.  Preparation and standardization JatyadiGhrita Suppository.

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

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

4. Tocompare the clinical efficacy in both the groups.

MATERIAL AND METHODS

Study design:

Itis a randomized openlabel comparative clinical study

Sampling technique :

Thesubjects who fulfil the inclusion criteria and complying with the informedconsent (IC) will be selected using random sampling (lotterymethod) technique.

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

3. The data obtained in all groupswill 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 DharmasthalaManjunatheshwara college of Ayurveda & Hospital, Hassan, for the study.

Method of collection of data:

200 patients whofulfil the inclusive criteria irrespective of gender, religion, economic statuswill be selected for the study using random samplingtechnique (lottery method).

Diagnostic criteria:

Classicalsigns & symptoms of Parikartika (Fissure-in-ano) as mentioned in classicaltexts.

·      Gudagata Shoola (Painfuldefecation)

·      Daha (Burning sensation per rectum)

·      Vibandha (Constipation)

·      Gudagata Rakta Srava(Bleeding per rectum)

·      Anorectal examination

Operational definitions/Techniques employed:

Study design:

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

Standard group:

·      PoorvaKarma – Complete evacuationof bowel

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

·      PradhanaKarma – 1gm (2 fingertip units) Jatyadi Ghrita tobe applied locally twice daily

·      Paschat****Karma - Advise the subject tomaintain the hygiene.

·      Tab. Triphala 2-0-2 afterfood

·      Assessmentwill be done on BT and at the end of everyweek of treatment.

·      Followup: Every fortnightly for a  period of 1 month

Trial group

·      PoorvaKarma- Completeevacuation of bowel.

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

·      PradhanaKarma – In lithotomypositionsubject is advised, to insertwell lubricated (with plain Ghrita) Jatyadi kashayadravya suppository into anal canal, twice daily.

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

·      Advise the subjectto maintain the hygiene.

·      Tab Triphala  2-0-2 after food

·      Assessmentwill be done on BT and at the end of everyweek of treatment.

·      Followup: Every fortnightly for a period of 1 month

Total duration of the study: 8 weeks

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

4 weeks of follow up once in 15days.

Assessment criteria:

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

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

Assessmentof study was done based on following parameters.

Primary outcome measures :

1.Pain - Vas Scale

2.Bleeding per Rectum

3.Itching – Numerical Rating

4.Stoolconsistency

5.Burningsensation

Secondaryoutcome measures:

1.Wound  healing

2.Sphincter tone