Post operative pain management of anorectal surgeries using herbal rectal suppository

Phase 2

Completed

Conditions: Anorectal fistula, (2) ICD-10 Condition: K601||Chronic anal fissure, (3) ICD-10 Condition: K92||Other diseases of digestive system, (4) ICD-10 Condition: K648||Other hemorrhoids,

Registration Number: CTRI/2018/09/015826

Lead Sponsor: Government Ayurveda Medical CollegeBengaluru

Brief Summary: Suppositories are one such dosage form thatcan be used in post-operative pain especially in anorectal surgeries. Sodiumdiclofenac is of NSAID category which has been shown to have analgesic effectsin various conditions.

Though diclofenac rectal suppositoryis widely used they are associated with high risk factors and warnings likeheadache, dizziness, light headedness, drowsiness, loss of appetite, localrectal irritation, ringing in the ears, vision loss, rectal bleeding. Otherserious side effects like blackstools, persistent stomach pain,vomit that looks like coffee grounds could develop. Allergic reactions likerashes, itching, swelling, trouble breathing could also develop as an adverseeffect of diclofenac suppository.5

According to Ayurveda, parikartika is avyadhi caused by vata and pitta dosha and anuvasana basti is treatmentexplained. But this involves a lot of exercise.The patient should be advisedwith pathya and apathya of both ahara and vihara, the basti dravya must bewarmed priorly before instillation, care should be taken to avoid bastivyapaths and the patient will always need the assistance of his doctor fortreatment. Most of these problems can be avoided by using an appropriatedravya(vata pitta hara, shoola hara) converted to a suppository form by beingmolded with a snigdha dravya which still satisfies the definition of basti(vasnivase) by staying in the rectum for a stipulated period of time andfacilitating slower drug release to provide a better action.

To prevent all these problems and toprevent the adverse effects of allopathic drugs the present study is planned toevolve an effective treatment by ayurvedic approach in post-operative painmanagement. In this study an attempt is made to evaluate the efficacy ofGandhaka Rasayana rectal suppository which is tridosha shamaka, vatamayanivaraka agnivardhaka, rasayana and most importantly shoola hara.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20

Inclusion Criteria

patients between age group of 20-60yrs 2)Patients undergoing fissurectomy, haemorrhoidectomy and fistulotomy.

Exclusion Criteria

1. pregnant women 2)Fissure/haemorrhoid/fistula in ano with Inflammatory Bowel Disease and Crohnâ€™s disease.
3)Patients with immunocompromised state.
4)Patients suffering from systemic diseases like DM,Tuberculosis,rheumatoid arthritis etc.
5)Positive cases for Human Immunodeficiency Virus (HIV), Venereal Disease Research Laboratory (VDRL) and hepatitis-B.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to attain Post operative pain management	5days , postoperatively

Secondary Outcome Measures

Name	Time	Method
To also elicit any wound healing activity along with the same	5days, post operatively

Trial Locations

Locations (1): Government Ayurveda Medical College Bengaluru
🇮🇳
Bangalore, KARNATAKA, India
Government Ayurveda Medical College Bengaluru
🇮🇳Bangalore, KARNATAKA, India
Dr Shilpa PN
Principal investigator
9886792113
drshilpamys@gmail.com