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Clinical Trials/CTRI/2024/11/077081
CTRI/2024/11/077081Not yet recruitingNot Applicable

A Randomized Controlled Clinical Trial to evaluate the efficacy of Shwet Malahar against Shatadhaut ghrita for local application in the management of parikartika.

PDEAs College of Ayurved and Research Centre, Nigdi Pune1 site in 1 country60 target enrollmentStarted: December 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
The effect of Shwet Malahar will be accessed with the effect of Shatadhaut Ghrita for local application in parikartika assessment will be done by criteria like P/R Bleeding, Burning Sensation, Constipation, Parikartanvat vedana , Anal Spasm, Wound Healing.

Study Overview

Brief Summary

Now a day due to faulty lifestyle or irregularity in diet and diet timing and also sedentary lifestyle. In addition to change in diet and lifestyle, one is always under tremendous mental stress. All these causes disturb in digestive system which results in too many diseases amongst them anorectal disorder constitute an important group. On the basis of the clinical symptom the diseases fissure-in-ano has been classified into two verities; viz. acute fissure-in-ano and chronic fissure-in-ano. Either acute or chronic pain, bleeding, burning sensation is the main symptom of this condition. Pain is sometimes intolerable. In long standing cases it may be associated with hemorrhoids or a sentinel tag. Pruritus ani may be another symptom of this condition. On the basis of symptoms, the disease fissure-in-ano can be compared to the disease Parikartika according to Ayurveda, Parikarta / Fissure-in-ano is very common and painful condition. Acharya Sushrut has described the term Parikartika.

Aacharya Charak has also mentioned Parikartika as complication of vamana and virechana.

Rationale of the study -

There are some local applications are available in market, but they act as lubricant, give temporary relief from pain, they have no role in fissure healing. Shatadhaut Ghrita plays a role in local lubrication, relief pain and the heals the ulcer also, but the procedure of its preparation is difficult and time consuming. Also in 100 washes its quantity gets reduces, which increases the cost.

In market Shatadhaut Ghrita is available, as it is prepared for commercial purposes there is doubt as it is prepared as giving 100 washes. The aim is to prepare simple remedy which is easy to apply, cost effective and gives local lubrication, relives pain and heals the ulcer.

Thus, in this study, the attempt is being made to observe the effect of "Shwet Malahar" in treatment of Parikartika. Moreover, there has been no work carried out on topical management of Parikartika with "Shwet Malahar". Hence, an attempt is being made to see the effect of "Shwet Malahar" instead of any surgical intervention.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Patients having anal spasm, sentinel tag and visible fissure during P/R examination will be included.

Exclusion Criteria

  • 1.Patients having Parikartika (Fissure-in-Ano) secondary to Ulcerative colitis, Chron’s Disease 2.Known case of.
  • Syphilis, Tuberculosis, Uncontrolled Diabetes, and Carcinoma of rectum.

Outcomes

Primary Outcomes

The effect of Shwet Malahar will be accessed with the effect of Shatadhaut Ghrita for local application in parikartika assessment will be done by criteria like P/R Bleeding, Burning Sensation, Constipation, Parikartanvat vedana , Anal Spasm, Wound Healing.

Time Frame: Patient will be followed up on 5th, 10th, 15th, and then 21st.

Secondary Outcomes

  • NA(NA)

Investigators

Sponsor
PDEAs College of Ayurved and Research Centre, Nigdi Pune
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Vaishnavi Rajan More

PDEAs College of Ayurved and Research Centre,Nigdi,Pune

Study Sites (1)

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