Clinical trial in Chronic fissure in ano

Phase 1/2

Recruiting

• Conditions: PARIKARTIKA FISSURE IN ANO

• Registration Number: CTRI/2016/02/006679
• Lead Sponsor: IPGT RA GAU Jamnagar Gujarat India

Brief Summary

This study is open label comparative clinical study of ksharsootra application and lateral internal sphincterotomy in the management of parikartika (fissure in ano). Routine blood investigation will be performed to rule out other systematic pathology. Special scoring scale has been prepared based on information in Ayurvedic classical texts which will be utilized for assessment and evaluation

**MATERIALS** **& METHODS:**

·         **Selection** **of patient:**

1.      Patients of *Parikartika* (Chronic fissure-in-ano) will be selected from OPD /IPD of Shalya Tantra, I.P.G.P.T. &R.A. Hospital, Jamnagar, irrespective of gender, occupation, religion, etc.

2.      The patient will be registered and randomly divided into two groups.

3.      The patients shall also be collected from the special camps organized outside the city & they would be admitted in I.P.G.T. & R.A. Hospital, Jamnagar.

**METHOD:**

·         **Grouping** **of Patients :**

The patients shall be randomly divided into two groups A & B, having 15 patients in each group.

**Group-A:**  Apamarg *Ksharasootra* application with transfixation of sentinel tag.

**Group-B:**  Lateral internal sphincterotomy followed by excision of sentinel tag.

**Management:**

·         **Pre-Operative (Common for both groups):**

1.    Fitness of patient

2.    Evacuation of bowel with soap water enema.

3.   Local Anesthesia

4.    CONSENT- written informed consent will be taken.

 Â·         **Operative** **Procedure**

**Group-A**

1. Patient laid in lithotomy position, painting & draping will be done.

2. Procedure will be carried out under local anesthesia (Inj. Xylocaine 2% with adrenaline).

3. Ligation of sentinel tag will be done with Apamarga *Ksharasootra* after maximum possible dilatation*.*

4. The operation will be carried out in OT and under aseptic precautions.

1. **Group-B**1. Patient laid in lithotomy position, painting & draping will be done.

2. Procedure will be carried out under local anesthesia (Inj. Xylocaine 2% with adrenaline).

3. Lateral internal sphincterotomy followed by excision of fissure with sentinel tag will done.

4. The operation will be carried out in OT and under aseptic precautions.·         **Post-Operative(Common for both groups):**

1. Warm water sitz bath along with *panchwalkal* *kwath*, two times a day.

2. *Erandbhrishta* *Haritaki* *churna*- 5 gm at bed time with luke warm water daily.

3. *Matra* *Basti* with *Jatyadi* *Tail* -10 ml, once daily after sitz bath. Â·         **Duration of treatment:**

Single sitting operation and adjuvant therapy up to complete wound healing or maximum four weeks.

·         **Follow-up Period:** One month

·         **Laboratory Investigation:**

a.     CBC

b.     FBS, PPBS.

c.     Blood urea, Sr. Creatinine, Sr. Billirubin if required

e.     HIV, VDRL, HBsAg

f.     Urine analysis- Routine & Microscopic

·         **Other Investigation:**

a.     Chest X-Ray – if required for fitness.

b.     ECG – if required for fitness.

c.     USG Abdomen & Pelvis – if required.

d.    Colonoscopy – if required.

**ASSESSMENT** **CRITERIA:**

Assessment will be done on the basis of specially prepared Performa for assessing relief in sign & symptoms by scoring pattern.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-03
• Last Update Posted: 2015-06-11

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients of Parikartika Chronic fissure in ano having duration more than 6 months.

Exclusion Criteria

1 Fissure in ano having duration less than 6 months 2 Patient suffering from malignancy 3 Patient suffering from HIV VDRL HepatitisB TB 4 Chronic fissure in ano associated with piles and fistula 5 Uncontrolled cases of Diabetes Mellitus and Hypertension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment will be done on the basis of specially prepared Performa for assessing relief in sign and symptoms by scoring pattern	1 month

Secondary Outcome Measures

Name	Time	Method
Assessment will be done on the basis of specially prepared Performa for assessing relief in sign and symptoms by scoring pattern	1 month

Trial Locations

Locations (1)

IPGT RA Hopsitaal Gujarat Ayurved University Jamnagar; 🇮🇳 Jamnagar, GUJARAT, India

IPGT RA Hopsitaal Gujarat Ayurved University Jamnagar

🇮🇳Jamnagar, GUJARAT, India

Manoj Bhadja

Principal investigator

09727871722

bhadjamanoj@gmail.com