Ayurvedic management of Parikartika(Fissure in Ano)

Completed

• Conditions: Acute anal fissure. Ayurveda Condition: PARIKARTIKA,

• Registration Number: CTRI/2022/05/042470
• Lead Sponsor: Dr Shivraj Dnyaneshwar Navale

Brief Summary

**TITLE**

**"A CLINICAL STUDY TOEVALUATE THE EFFICACY OF RAKTACHANDAN MALHAR (LOCALLY) ALONG WITH HARITAKICHURNA VATI (INTERNALLY) IN THE MANAGEMENT OF PARIKARTIKA W.S.R. TO FISSURE INANO"**

**AIM AND OBJECTIVES**

**AIM:**

TO STUDY THECLINICAL EFFICACY OF RAKTACHANDAN MALHAR(LOCALLY) ALONG WITH HARITAKI CHURNAVATI (INTERNALLY) IN THE MANAGEMENT OF PARIKARTIKA W.S.R. TO FISSURE IN ANO.

**OBJECTIVES:**

**Primary:**

•       To evaluate the effect of*Raktachandan Malhar (Locally)* in the management of symptoms such asBurning sensation, Pain, Anal sphincter Spasm, Ulcer and Bleeding P/R.

•       To establish *Raktachandan*Malhar as local (user friendly), cost effective treatment for Parikartikaw.s.r. to fissure in ano.

•       To review the Ayurvedicand Modern literature in context to Parikartika and Fissure in Ano andadvancement in its management.

**RESEARCHQUESTION:** -

•        Is *Raktachandana Malhar (Locally) alongwith Haritaki churna Vati (Internally)* effective in the management ofParikartika w.s.r. to fissure in ano?

 **Hypothesis: -**

 **Null Hypothesis: -**

•       *Raktachandana Malhar(Locally) along with Haritaki churna Vati (Internally)*is not effective in the management of Parikartika w.s.r. to fissure in ano.

 **Alternate Hypothesis: -**

•        *Raktachandana Malhar (Locally) along withHaritaki churna Vati (Internally)* is effective in the management ofParikartika w.s.r. to fissure in ano.

**Method of preparation of Raktachandan malhar**

Raktachandana kwathwere prepared as per authentic procedures of preparation. The coarse powder ofRaktachandan stored in a vessel and soaked with water then boiled with 16 timesof water until it reduces to a quarter.Then TilaTaila was taken in a suitable pot heated on the flame till bubbles rise off.Tila Taila Murchhana was done and allowed it to cool by itself Then 1 part of kwathwas added into 1 part of Tila Taila and mandagni till khara paak awashta wasachieved. Then taila was sieved, collected in clean and sterile container.

**Malhar nirman vidhi**

Some Base material is required forpreparation of Malhar and Siktha (Bee Wax) is one among them. So, we are usingsiktha as a base to prepare *Raktachandan* Taila Malhar.

Malhar nirman vidhi:

Ratio of Siktha to taila is taken as1:5 respectively.

As there is no direct reference ofpreparation of Raktachandan Taila Malhar, it was prepared by common method ofpreparation of Malhar kalpana explained in Rasatarangini. 1 part of bee wax(siktha) is added to the 5 parts of RaktachandanTaila.

After heating the taila, the beewax was added and stirred well. After complete melting of bee wax, flame wasswitched off and continuous stirring of mixture was done till the final product(Malhar) is obtained. It was stored in container and was observed till itattained semi-solid consistency.

**PREPARATION OF HARITAKI CHURNA VATI**

Raw dried fruit of Haritaki wastaken and its seeds was removed. Process the powder of haritaki. Pillsmeasuring 500mg each was prepared from the powder.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-16
• Study Completion: 2023-02-15
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Clinically diagnosed Patients of Acute fissure in ano (Onset upto 28 days) without Sentinel Tag & Anal papillae Patients among the age group 18 to 60 yrs irrespective of gender religion occupation educational status and socio-economic status.

Exclusion Criteria

• Chronic Fissure in Ano (Onset more than 28 days) with Sentinel Tag & Anal papillae Bleeding Disorder like Hemophilia etc Patient with uncontrolled systemic disease like diabetes and hypertension.
• Patient with Ca rectum.Patient having Parikartika secondary to Ulcerative colitis Syphilis Crohn’s disease, T.B. HIV Hepatitis etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to evalute the effect of Raktachandan Malhar(locally) in the management of symptoms such as burning sensation pain anal spincter spasm ulcer and bleeding P/R	28 days

Trial Locations

Locations (2)

D.Y PATIL DEEMED TO BE UNIVERSITY, SCHOOL OF AYURVEDA, NERUL NAVI MUMBAI.; 🇮🇳 Thane, MAHARASHTRA, India

DY Patil School of Ayurveda; 🇮🇳 Thane, MAHARASHTRA, India

D.Y PATIL DEEMED TO BE UNIVERSITY, SCHOOL OF AYURVEDA, NERUL NAVI MUMBAI.

🇮🇳Thane, MAHARASHTRA, India

Dr SHIVRAJ DNYANESHWAR NAVALE

Principal investigator

9834636348

shivrajnavale3@gmail.com