A clinical study to evaluate the efficacy of Yavadi Ghritam (Locally) along with Haritakichurna Vati (internally) in the management of Parikartika w.s.r. to Acute Fissure in Ano.

Title of study- â€œ A clinical study to evaluate the efficacy of Yavadi Ghritam (Locally) along with Haritakichurna Vati (Internally) in the management of Parikartika w.s.r. to Acute Fissure in Ano.Aim: To evaluate the efficacy of Yavadi Ghritam (Locally) along with Haritakichurna Vati (internally) in the management of Parikartika w.s.r. to Acute Fissure in Ano.

Objectives:

To evaluate the effect of Yavadi Ghritam (Locally) in the management of Symptoms such as burning sensation, pain, anal sphincter spasm, ulcer, bleeding P/R and Haritakichurna Vati (internally) in the management of constipation.

To To establish Yavadi ghritam as cost effective local formulation, easily available and completely herbal preparation without adverse effects for Parikartika w.s.r. to Acute Fissure in Ano.

Tt  To review the Ayurvedic and modern literature in context to Parikartika w.s.r. Acute fissure in ano and adavancement in its management.

Research Question-

Whether Yavadi Ghritam (Locally) along with Haritakichurna Vati (Internally) effective in management of Parikartika w.s.r to Acute Fissure in Ano.

Hypothesis-

**Null Hypothesis (H0)-**Yavadi Ghritam (Locally) along with Haritakichurna Vati (Internally) is not effective in management of Parikartika w.s.r to Acute Fissure in Ano.

**Alternate Hypothesis(H1)-**Yavadi Ghritam (Locally) along with Haritakichurna Vati (Internally) is effective in management of Parikartika w.s.r to Acute Fissure in Ano.

Methodology-

Source of Data – D.Y Patil Ayurvedic hospital, Navi Mumbai, Shalya Tantra dept., OPD No- 03

Type of study – Open, single arm, Clinical Study

Ethical clearance – Ethical clearance will be taken from ethical committee of Dr. D.Y Patil  Ayurvedic Hospital.

Consent- A understanding will be given to the patients about trial and a written consent will be taken  from the patient prior to participate in study.

Sample size – 50 patients

Material/Drug –

1.Local Use-Yavadi Ghritam

2.Internal Use- Haritakichurna Vati

Doses-Local application of Yavadi Ghritam with the help of applicator daily for 7 days (in morning before & after defecation & in night before sleeping hours).

Internally Haritakchurna Vati (500mg each) 4 tablets at night for 14 days.

Anupan- Koshn Jal (Lukewarm water).

Diagnostic Criteria-

1)Gudagata Shool (Pain).

2) Gudagat Rakta strava (P/R Bleeding).

3)  Malavstambh(constipataion)

4) Anal sphincter spasm

5) Anal Ulcer Healing

**Follow up-**1,7,14, 21, 28 Day

Method of Preparation of Ghrita-

Ingredients- 1)Yava Coarse powder +Yastimadhu Coarse powder (1:1) - 1 part

2)   Murchhita Ghrita & Til Taila (3/4 Parts Ghrita+1/3 Part Til Taila) – 4 Parts

3)   Water-16 PartS

**PREPARATION-**Preparation of Yavadi Ghritam will be done a/c Sushruta samhita chikitsha sthana chapter-31/8. First, Prepare Yavadi (Yava+Yashtimadhu) Kwath as per authentic procedures of preparation. Store the coarse powder of Yavadi (Yava+Yashtimadhu) in a vessel and soak with water then boil with 16 times of water until it reduces to a quarter. Take Til Taila and Ghrita suitable pot and heat separately on the flame untill the Sneha Siddhi is achieve. Do Til Taila  and Ghrita murchhana and allow it to cool by itself. Then 1 Part of kwath will be add into 1 part of Til Taila and Ghrita (1/4 Til Taila +3/4 Ghrita) and allow mandagni till madhyam pak awashtha is achieve. Then, processed Ghrita will be sieve and collect processed Ghrita in a clean and sterile container.

                    PREPARATION OF HARITAKICHURNA VATI-

·   Raw dried fruit of Haritaki will be taken and its seeds will be removed. Then processing of  the Haritaki Churna (powder) will be done*. (*a/c to sa. m. 6/1) then Vati measuring 500mg

each will be prepared from the powder.