| CTRI Number |
CTRI/2025/03/083136 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study compares two treatments, Shodhita Kasisadrava Basti and Kasisadi Taila Basti, to manage second-degree internal hemorrhoids and evaluate their effectiveness. |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Shodhita Kasisadrava Basti And Kasisadi Taila Basti In Management Of Arsha W.S.R. To Second Degree Internal Haemorrhoids-Open Label Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Darshana Ramole |
| Designation |
Professor Shalya Tantra |
| Affiliation |
Shree Swaminarayan Ayurvedic College, Kalol |
| Address |
OPD 006, Department Of Shalya Tantra, Premswarup Swami Ayurvedic Multispeciality Hospital, Teaching Hospital Of Shree Swaminarayan Ayurvedic College, Ahmedabad-Mehsana Highway At And Po Saij Ta.Kalol Dist.Gandhinagar. Gujarat
Gandhinagar
GUJARAT
382721
India |
| Phone |
9970728218 |
| Fax |
|
| Email |
drdarshna@swaminarayanuniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshana Ramole |
| Designation |
Professor Shalya Tantra |
| Affiliation |
Shree Swaminarayan Ayurvedic College, Kalol |
| Address |
OPD 006, Department Of Shalya Tantra, Premswarup Swami Ayurvedic Multispeciality Hospital, Teaching Hospital Of Shree Swaminarayan Ayurvedic College, Ahmedabad-Mehsana Highway At And Po Saij Ta.Kalol Dist.Gandhinagar. Gujarat
Gandhinagar
GUJARAT
382721
India |
| Phone |
9970728218 |
| Fax |
|
| Email |
drdarshna@swaminarayanuniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sagar Negi |
| Designation |
Pg Scholar Shalya Tantra |
| Affiliation |
Shree Swaminarayan Ayurvedic College, Kalol |
| Address |
OPD 006, Department Of Shalya Tantra, Premswarup Swami Ayurvedic Multispeciality Hospital, Teaching Hospital Of Shree Swaminarayan Ayurvedic College, Ahmedabad-Mehsana Highway At And Po Saij Ta.Kalol Dist.Gandhinagar. Gujarat
Gandhinagar
GUJARAT
382721
India |
| Phone |
7895396946 |
| Fax |
|
| Email |
sagarnegi121.sn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Swaminarayan Ayurvedic College and Hospital, kalol, Gandhinagar, Gujarat.382721 |
|
|
Primary Sponsor
|
| Name |
Shree Swaminarayan Ayurvedic College, Kalol |
| Address |
Shree Swaminarayan Ayurvedic College and Hospital, kalol, Gandhinagar, Gujarat.382721 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Darshana Ramole |
Premswarupswami Ayurvedic Multispeciality Hospital |
OPD 006, Department Of Shalya Tantra, Premswarup Swami Ayurvedic Multispeciality Hospital, Ahmedabad-Mehsana Highway At And Po Saij Ta.Kalol Dist.Gandhinagar. Gujarat
Gandhinagar
GUJARAT |
9970728218
drdarshna@swaminarayanuniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee shree swaminarayan ayurvedic college,Kalol |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Sharangdhar Samhita Madhyam Khand 9/142-143, Procedure details: 1) Under all aseptic precaution cleaning and draping will be done.2) Give left lateral position to the patient.3) Perianal region is cleaned with the betadine soaked gauze and then wiped with dry gauze.4) Then lubricate the anal region and tip of a red rubber catheter with LOX 2% jelly.5) A disposable syringe is filled with 30 ml Kasisadi Taila.6) Then medicine is administered slowly.7) After the procedure the patient is advised to lie in supine position for 30 minutes.)
(1) Medicine Name: Kasisadi Taila, Reference: Sharangdhar Samhita Madhyam Khand 9/142-143, Route: Rectal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 21 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Rastarangini, 21st tarang, Procedure details: 1) Firstly patient is advised to be empty stomach during the procedure.2) Give left lateral position to the patient.3) Perianal region is cleaned with the betadine soaked gauze and then wiped with dry gauze.4) Then lubricate the anal region and tip of a red rubber catheter with LOX 2% jelly.5) A disposable syringe is filled with 30 ml shodhita Kasisadrava.6) Then medicine is administered slowly.7) After the procedure the patient is advised to lie in supine position for 30 minutes.)
(1) Medicine Name: Kasisa Drava, Reference: Rastarangini, 21st tarang, Route: Rectal, Dosage Form: Dravaka, Dose: 30(ml), Frequency: od, Duration: 21 Days |
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|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and Female between 18-60 years.
2.2nd degree Internal Hemorrhoids. |
|
| ExclusionCriteria |
| Details |
1.Third degree and fourth degree haemorrhoids.
2.Active bleeding piles.
3.Associated other painful condition like fistula in ano, Perianal Abscess, Malignancy, Rectal prolapse, Rectal polyp etc.
4.Patient contraindicated for basti as per classics.
5.Acute inflammatory diseases of GIT.
6.Pregnancy.
7.Systemic diseases like uncontrolled DM and HTN. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Kasisadrava Basti in terms of controlling bleeding and prolapse in management of Arsha(second degree internal hemorrhoids) |
3 Consecutive Basti in a Week. Total 9 basti in 21 days.
Follow up after 45 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To promote the simple, traditional and cost effective treatment of management of Arsha
2.To promote the innovative treatment of second degree internal Haemorrhoids.
3.To study the haemorrhoids as per modern text and Arsha as per Ayurvedic text. |
3 Consecutive Basti in a Week. Total 9 basti in 21 days.
Follow up after 45 days. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Arsha (Hemorrhoids) is one the lifestyle disorder caused due to sedentary lifestyle in today s world. These are the clumps of dilated veins in the anus and lower rectum. In Ayurveda the disease in which Mamsa ankur(Fleshy masses) which occur at the opening of guda marg(anus), obstruct the pathway and trouble the person like an enemy is called Arsha. Modern surgeries which are in practice at present in modern surgery are sclerotherapy, rubber band ligation etc. But not all of them are uniformly successful.so this study aims to explore ayurvedic interventions for managing Arsha. Focusing on the effectiveness of Kasisdrava basti. Which is mentioned in Rastarangini 21/254. The study will involve 40 patients with second degree internal haemorrhoids and Patients will be divided into two groups Group A: 20 patients with 2nd degree internal haemorrhoids will be treated with Shodhita Kasisadrava Basti for inconsecutive 3 days in a week. Group B: 20 patients with 2nd degree internal haemorrhoids will be treated with Kasisadi taila basti for consecutive 3 days in a week. Follow up after 45 days. Patients will be assessed based on the presence of bleeding and Prolapse. |