Effect Of Tilvak Pratisarniya Kshara In Abhyantar Arsha (Internal Haemorrhoids)

Phase 2/3

Not yet recruiting

Conditions: Other specified diseases of the digestive system. Ayurveda Condition: ARSAH,

Registration Number: CTRI/2025/04/084320

Lead Sponsor: Gawali Pranil Rajendra

Brief Summary: After clearance of institutional ethics of Government Ayurveda College Nagpur screening of population will be done from patient in OPD and IPD of our institute. In clinical study of 30 patients in each group of Abhyantar Arsha will be include. If patients fulfill the criteria of inclusion, subject would also give freedom to ask their questions all questions would answer. If he/she agrees for participation in study and found fit to include the patient will include in the study.

Patients will be randomly divided into two groups as follows:

GROUP A: Tilvak Kshara

Application of Kshara: As per required

Duration of treatment: 12 Days 4 Settings (On every 4th Day) (0th-4th-8th-12th)

Observation: for 16 days (0th-4th-8th-12th-16th)

GROUP B: Apamarga Kshara

Application of Kshara: As per required

Duration of treatment: 12 Days 4 Settings (On every 4th Day) (0th-4th-8th-12th)

Observation: for 16 days (0th-4th-8th-12th-16th)

The patients will assess on the following parameter and the relevant data

will be collected for analysis

1.Per Rectal Bleeding (Gudagat Raktastrava)

2.Size of pile mass

3.Colour of pile mass

4.Mucous discharge

5.Pain associated with defecation

6.Pruritis

Medium of Dissertation: The study will be written in English and Sanskrit words will be used wherever necessary

STUDY DESIGN: Open labelled Randomised Controlled Trial

DURATION OF STUDY: 18 months after Approval of Synopsis

STUDY POPULATION: Patients attending OPD and IPD of Shalya Tantra Department having signs and symptoms of Abhyantar Arsha (Internal Haemorroids).

It is estimated based on the effect of therapy of Apamarga Kshara application on management of Abhyantar Arsha (Internal haemorrhoids) reported in published article [Ref. Sudarmi K, Dudhamal TS. Comparative clinical study of Apamarga Kshara application, infrared coagulation and Arshohara Vati in the management of Arsha (1st and 2nd degree Hemorrhoids). Ayu. 2017 Jul-Dec;38(3-4):122-126. doi: 10.4103/ayu.AYU\_94\_17. PMID: 30254391; PMCID: PMC6153910.] with following assumptions:

1. % of effect of therapy of Apamarga Kshara application in the

management of Arsha (1° and 2° haemorrhoids) – 87.5%

2. % of effect of therapy of Tilvak Kshara application in

management of Arsha (1° and 2° haemorrhoids) – 89%

3. Proportion in standard treatment – 0.875

4. Proportion in the new treatment – 0.89

5. Observed/Expected difference in proportion – 0.02

6. Superiority margin in proportion – 0.25

Required sample size per group is 24

Considering 20% drop out or lost from cooperative.

Final sample size is 30 per group

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients willing to participate in study.
Patients having age between (18) to (60) yrs will be selected for the study.
Patients having (I°) and (II°) Internal Haemorroids.
Patients will be selected irrespective of sex, religion, marital status, educational and economic status.
Patients having symptoms like Per rectal bleeding, Pain, Itching, Mucous discharge.
Patients having controlled DM (70-180 mg/dl) will be selected.
Patients having controlled HTN.

Exclusion Criteria

Patients having (III°) and (IV°) Haemorrhoids.
Patients having uncontrolled DM (BSL greater than 180mg/dl).
Severe anaemic patients.
(Hb lesser than 8 gm%).
Patients of Internal Haemorrhoids with acute fissure in ano.
Haemorrhoids with pelvirectal or ischiorectal abscess.
Patients requiring any medical emergencies.
Patients requiring immediate surgical action.
Non-co-operative patients.
Immuno-compromised patients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Evaluate the efficacy of Tilvak Kshara Pratisarana in the management of Abhyantar Arsha (Internal Haemorrhoid)	On the 0th,4th,8th,12th day of trial

Secondary Outcome Measures

Name	Time	Method
To Evaluate the efficacy of Apamarga Kshara Pratisarana in the management of Abhyantar Arsha (Internal Haemorrhoid)	To compare the efficacy of Tilvak Kshara Pratisarana and Apamarga Kshara Pratisarana in the management of Abhyantar Arsha (Internal Haemorrhoid)

Trial Locations

Locations (1): Government Ayurved College and Hospital, Nagpur, Maharashtra, India, 440024
🇮🇳
Nagpur, MAHARASHTRA, India
Government Ayurved College and Hospital, Nagpur, Maharashtra, India, 440024
🇮🇳Nagpur, MAHARASHTRA, India
Dr Pranil Rajendra Gawali
Principal investigator
8928918799
pranilraje99@gmail.com