To Know the most effective treatment in between medicated thread of Apamarg and lateral cut inside to the sphincter in Chronic Fissure in Ano

Completed

• Conditions: Fissure in Ano

• Registration Number: CTRI/2017/10/009963
• Lead Sponsor: Not Any

Brief Summary

**SUMMARY**

The research study entitled “Acomparative clinical study of *ApamargKsharasootra* and Lateral Internal Sphincterotomy in the management of *Parikartika* (Chronic Fissure-In-Ano)- An open randomized Trial. †Aim andObjective of this study was to compare *ApamargaKsharasootra* application and Lateral Internal Sphincterotomy in themanagement of *Parikartika* (ChronicFissure-in-ano). This trial is summarized in Literature review, Ayurvedic literature& Modern literature of *Parikartika* (ChronicFissure in ano). For this trial Nullhypothesis (H0) was the effect of *ApamargaKsharasootra* and open lateral internal sphincterotomy  in the management of *Parikartika* (Chronic fissure in ano) will be same. Alternative hypothesis(H1) was the effect of *ApamargKsharasootra* application and Latral Inernal Sphincterotomy in themanagement of Parikartika (Chronic fissure in ano) will not be same. Drugreview included description of *ApamargaKshara* and *Ksharasootra* Preparation,SOP of *Kshara* preparation and theiringredients detail with their properties and mode of action were discussed withclassical references. Adjuvant drugs was given in both groups were alsodiscussed with their probable mode of action.

Total105 patients of *Parikartika* (ChronicFissure in Ano) were selected & randomly divided by computerized randomizedtable. In Group A (n=52) patients treated with trial *Ksharasootra* application with maximum possible anal dilatation wasdone while in group-B (n=53) Lateral Internal Sphincterotomy (LIS) was doneunder LA. or S.A. *Jatyadi Taila MatraBasti, Panchawalkala Kwatha* for*Avagaha Swedana, Erandbhrishta Haritaki* orally for laxative were used inpost-operative period as adjuvant drugs in both groups. Before treatment,routine hematological, biochemical, urine examination were carried out. Theassessment was made on the basis of relief in pain, oozing and days requiredfor complete wound healing after operation. In this study, assessment was doneon 7th day, 14th day, 21st day and on 30th post-operative day and Follow up wastaken after 1 month. The observed results in the study were subjected tostatistical calculation to derive final conclusion.

Thediscussion was made on all demographic observations and clinical findings i.e.In group-A average 11.75 days required for relief in pain in ano while ingroup-B average 09.84 days required for relief in pain in ano, which shows thepatients of Group-B got relief in pain earlier than patients of Group-A. Inthis study, it was observed that 92.16% patients got relief in post-operativeoozing of blood till 1st week in group-A, 100% patients got relief in P/Rbleeding within 14th days in group-A and 89.26% patients got relief in P/Rbleeding within 7th days in group-B. This means after Sphincterotomy more daysrequired for stoppage of oozing of blood. It was observed that 50.00% patientsgot relief in post-operative swelling till 1st week in group-A, 100% patients got relief in post-operative swellingwithin 14th  days in group-A and 33.33%patients got relief in post-operative swelling within 7th days in group-B and100% patients got relief in post-operative swelling within 14th days. *Vibandha* (Constipation) was relieved in49 patients of Group-A and 48 patients of Group-B have constipated bowel (*Vibandha*) which  was relieved within 7 days. In 83.50% patientsof Group A and 16.49% of patients of Group B needed other laxative drug forrelief in constipation after operation.

Conclusion-In both groups highly significant results were found statistically but earlyrelief in post-operative pain were observed in Group-B (Lateral InternalSphincterotomy with excision of skin tag) whereas early relief inpost-operative swelling and oozing were observed in Group-A (*Ksharasootra* application with maximumpossible anal dilatation).

HenceNull hypothesis (H0) is rejected and Alternative hypothesis (H1) is acceptedi.e. a significant effect of *ApamargKsharasootra* application in the management of Fissure in ano.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-19
• Study Completion: 2019-04-01
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients of Parikartika (Chronic fissure-in-ano) having duration more than 6 months.
• Age group between 18-60 years.

Exclusion Criteria

• 1. Fissure-in-ano having duration- less than 6 months.
• 2. Chronic fissure-in-ano associated with piles & fistula.
• 3. Patient below 18 & above 60 years of age 4) Patient suffering from HIV, VDRL, HepatitisB, T.B. 5) Uncontrolled cases of Diabetes Mellitus and Hypertension.
• 6. Patient suffering from malignancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apamarga Ksharasootra is more effective than lateral internal sphincterotomy	1 month

Secondary Outcome Measures

Name	Time	Method
lateral internal sphincterotomy is more effective than apamarga ksharasootra	0, 7th , 14th, 21th, 30th day

Trial Locations

Locations (1)

Institute for Post Graduate Teaching and Research in Ayurveda; 🇮🇳 Jamnagar, GUJARAT, India

Institute for Post Graduate Teaching and Research in Ayurveda

🇮🇳Jamnagar, GUJARAT, India

Gajiram Banothe

Principal investigator

7046243508

amanbanothe@gmail.com