“A Comparative Clinical Study OfYashtimadhu Ghrita And Lignocaine-Nifedipine Ointment In The Management Of Parikartika (Acute Fissure- In- Ano).â€
- Conditions
- PARIKARTIKA ( ACUTE FISSURE IN ANO)
- Registration Number
- CTRI/2016/11/007496
- Lead Sponsor
- IPGT AND RA GAU JAMNAGAR
- Brief Summary
This study is open label comparative clinical study of local application of yashtimadhu ghrita and lignocaine-nifedipine in the management of parikartika (acute fissure in ano)
Routine blood investigations will be performed to rule out others .
special scoring scale has been prepared based on information in
ayurvedic classical texts which will be utilized for assessment and evaluation
**METHOD:**
· **Grouping** **of Patients :**
The patients shall be randomly allocated into two groups A & B, having minimum 15 patients in each group.
**Group-A:** Local application of *Yashthimadhu Ghrita* in fissure bed (*Parikartika*) twice a day after sitz bath for 4 weeks.
**Group-B:** Local application of Lignocaine-nifedipine ointment in fissure bed *Parikartika* twice a day after sitz bath for 4 weeks.
· **Common Treatment for both groups:**
**1.** Warm water sitz bath with *Panchavalkal Kwath*, twice a day.
2. *Erandbhrist Haritaki Churna* 5gms HS (at bed time) with luke warm water.
· **Procurement of trial drugs**
*Yashtimadhu ghrit*will be procured from pharmacy of Gujrat Ayurved University, Jamnagar.
Lignocaine-nifedipine ointment (anobliss or any branded ointment) will be procured from local market.
· **Duration of treatment**
Four weeks
· **Follow-up Period:** One month
· **Laboratory Investigation:**
a. CBC
b. RBS,
c. Blood urea, Sr. Creatinine, Sr. Billirubin.
e. HIV, VDRL, HBsAg
f. Urine analysis- Routine & Microscopic
g. Stool examination- Routine & Microscopic
· **Other Investigation:**
Chest X-Ray, ECG, USG Abdomen, Colonoscopy if required.
**OVERALL ASSESSMENT** **CRITERIA:**
Patients will be assessed as per following gradation:
1. Complete remission: 100 % improvement in subjective and objective parameter
2. Marked improvement: 76 – 99 % relief in subjective and objective parameter
3. Moderate improvement: 51 - 75 % relief in subjective and objective parameter
4. Mild improvement: 26 - 50 % relief in subjective and objective parameter
5. Unchanged: Less than 25 % relief in subjective and objective parameter
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 30
- 1.Patients of Parikartika (Acute fissure-in-ano) having duration less than 12 weeks.
- 2.Controlled cases of Diabetese mallitus or Hypertension.
- 1.Fissure-in-ano having duration- more than 12 weeks.
- 2.Patient below 17 & above 70 years of age.
- 3.Patient suffering from malignancy.
- 4.Patient suffering from HIV, VDRL, Hepatitis-B, T.B. 5.Fissure-in-ano associated with piles & fistula.
- 6.Multiple fissure in ano 7.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 ASSESSMENT WILL BE DONE ON THE BASIS OF SPECIALLY PREPARED PERFORMA FOR ASSESSING RELIEF IN SIGN AND SYMPTOMS BY SCORING PATTERN
- Secondary Outcome Measures
Name Time Method 1 MONTH 1 MONTH
Trial Locations
- Locations (1)
IPGT AND RA GAU
🇮🇳Jamnagar, GUJARAT, India
IPGT AND RA GAU🇮🇳Jamnagar, GUJARAT, IndiaJIGNA PATELPrincipal investigator9033307475dr.jignapatel48@yahoo.com