| CTRI Number |
CTRI/2024/10/075458 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative study of Katutumbi bijadi Guda varti with Apamarga Ksharasutra Ligation in patients of Arshas. |
|
Scientific Title of Study
|
A Randomized Controlled clinical study of Katutumbi bijadi Guda varti with Apamarga Ksharasutra Ligation in the patients of Arshas(II and III Degree Haemorrhoids) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanneeru Lakshmi Gowri |
| Designation |
Post graduate scholar |
| Affiliation |
S V Ayurvedic college and Hospital |
| Address |
Department of Shalya Tantra
S V Ayurvedic college and Hospital
SVIMS Campus
Tirupati
Chittoor
Chittoor ANDHRA PRADESH 517507 India |
| Phone |
9000557928 |
| Fax |
|
| Email |
laksmigowri1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K V Vijaya Bhaskara Reddy |
| Designation |
Professor and HOD |
| Affiliation |
S V Ayurvedic college and Hospital |
| Address |
Department of Shalya Tantra
S v Ayurvedic college and Hospital
SVIMS Campus
Tirupati
Chittoor
Chittoor ANDHRA PRADESH 517507 India |
| Phone |
9849451333 |
| Fax |
|
| Email |
drkvbreddy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Tanneeru Lakshmi Gowri |
| Designation |
Post graduate scholar |
| Affiliation |
S V Ayurvedic college and Hospital |
| Address |
Department of Shalya Tantra
S V Ayurvedic college and Hospital
SVIMS Campus
Tirupati
Chittoor ANDHRA PRADESH 517507 India |
| Phone |
9000557928 |
| Fax |
|
| Email |
laksmigowri1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.V. Ayurvedic College and Hospital,SVIMS CAMPUS,Tirupati,Andhra Pradesh-517507 |
|
|
Primary Sponsor
|
| Name |
S.V. Ayurvedic College and Hospital |
| Address |
SVIMS CAMPUS, Tirupati, Andhra Pradesh 517507 |
| Type of Sponsor |
Government 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 |
| Tanneeru Lakshmi Gowri |
S.V. Ayurvedic College and Hospital |
OP number-5, Department of Shalya Tantra, S.V. Ayurvedic College and Hospital, SVIMS CAMPUS, Tirupati.
ANDHRA PRADESH
517507
India Chittoor ANDHRA PRADESH |
9000557928
lakshmigowri1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of TTDs S.V. Ayurvedic College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, (2) ICD-10 Condition:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | gudavarti, गà¥à¤¦à¤µà¤°à¥à¤¤à¤¿ | (Procedure Reference: Bhaisajya Ratnavali 9/14, Procedure details: The patients who were diagnosed with Arshas are to be advised to undergo the routine investigations & viral markers. After checking all the reports thoroughly, the patient should advised to consume light diet on the day of treatment & should be conform about clear evacuation of bowels. After Conforming about the bowel passage, the patient should made to be lie down in a left lateral position on the examination table, then local part should be cleaned with swabs & then mopped dry with sterile gauze. Then anal canal should be lubricated with Go gritha. Afterwards katutumbi bijadhiadhi Gudavarti should be kept in the anal canal. After 15 min, the part should be washed thoroughly & then local packing has to be done. Patients should be advised to take sitz bath twice daily. All the patients should be advised to take buffalo curd diet during course of treatment. This procedure is repeated for two consecutive days. Then after completion of 3 days of treatment with Katutumbi bijadi gudavarti, progress of the patient is observed for every week for 1 month. )
|
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having signs and symptoms of Arshas.
2)Patients with age ranging from 18 years to 65 years with irrespective of gender.
3)Patients having II & III degree Haemorrhoids. |
|
| ExclusionCriteria |
| Details |
1)Concomitant Ano-rectal conditions like Fistula-in-Ano, Fissure - in -Ano, ulcerative
colitis, Malignancy.
2)Pregnant women.
3)Patients of Portal hypertension.
4)Patients of Chronic kidney diseases.
5)Patients of Tuberculosis.
6)Patients of Inflammatory bowel disease.
7)Patients of Uncontrolled diabetes. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out whether this study drug regress the size of Arshas and prevents the recurrence of Arshas. |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out safe, simple, effective and economical method of treating Arshas. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2024 |
| 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="6" 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
|
|
Brief Summary
|
In Ayurveda, since Vedic period Arshas has been the main area of concern among anorectal
disease. The great Indian Surgeon Susrutha known as father of surgery has described Arshas in
Susrutha samhitha Nidana sthana 2
nd chapter (K.R..Srikantha Murthy,2017, p.233) and its
chikitsa in Chikitsa sthana 6th chapter. He considered Arshas as one of the Astha Mahagadas
means diseases which are very difficult to treat. Arshas is an torious for its troublesome pain like
enemy, which afflicting mankind for thousands of years. This condition can be correlated with Haemorrhoids in modern science, in which dilated veins
within the anal canal in the sub-epithelial region formed by radicals of superior, middle and
inferior rectal veins. Haemorrhoids are engorgement of the Haemorrhoidal venous plexus,
characterized by bleeding per rectum, constipation, pain, prolapse and discharge. Acharya Susrutha has mainly narrated the four types of treatment modalities for successful
management of Arshas viz., Bhesaja [Internal and external medications], Shastra [Surgical
methods], Kshara [Caustic cauterization], and Agnikarma [Thermal cauterization]. Despite of many more modern treatments like Rubber band ligation, Sclerotherapy,
Photocoagulation, Cryosurgery, Haemorrhoidectomy, etc., Ayurveda is well known for the
treatment of Arshas for its negligible rate of recurrence, cost effective, less chances of pain,
Haemorrhage, infection and anal incontinence. According to Bhaisajya ratnavali, only three applications of Gudavarti prepared by pounding
Tumbi bija and Audbhida lavana with kanji alleviate Arshas. During the course of treatment, the
patient is to be kept on Buffalo’s curd diet. Gudavarti are solid dosage preparations which are prepared by moulding or compression
methods intended for its insertion into rectum. It facilitates vata anulomana and which there by
eases the expulsion of Mala and also intended to exhibit udavarthahara karma. Katutumbi beeja
is having katu vipaka and which has anti-thrombotic property makes bandana of sonitha srava.
Because of having tikta rasa it acts on tvak and mamsa dhatu makes mamsa sthirikarana which
may prevents degenerative process in collagen fibers and fibro-elastic tissue. That which may
help’s in reducing the congestion and pooling of blood from the hamorrhoidal masses and
increases the tone of vasculature so that mass start decreasing in size gradually and in the end it
may completely shrinks the mass. There are several therapeutic reasons affecting bioavailability of drugs from rectal suppositories,
one among these is to partly avoid hepatic first- pass elimination or metabolism following rectal
administration. Colorectal absorption is a simple diffusion process through the lipoidal
membrane in which there is carrier mediated mechanism. It is also believed that rectal pH of
about 7.3 provides a convenient environment for the drug to be chemically stable on insertion.
No issues with oral compliance of the patient thus avoiding nausea and vomiting. It also proves
to be a convenient drug delivery option in patients especially with rectal complaints. The rectal
temperature ia around 37.8ºC-38.9 ºC where as the melting point of this prepared Gudavarti is
36ºC which is easly soulbe in rectal temperature and hence play a good mode of action. Among the four treatment modalities in Arshas mentioned by susrutha, kshara karma and
Agnikarma are considered as para-surgical procedures. These para-surgical procedures are
having many advantages viz., They are simple, safe, effective, ambulatory and minimal or no
complications, less time to study in hospital and minimal interference in patients routine work. Ksharasutra treatment is very suitable and acceptable as compared to prevalent methods in
modern medical science. Even though, it has been accepted by medical society for its good
efficacy in treatment of Bhagandara there is still need in of standardization of Ksharasutra
Ligation in the treatment of arshas.The Ksharasutra ligation performs excision by virtue of its
mechanical pressure and phytochemical cauterization effect and ligation is expected to reduce
the engorgement and finally peels the lesion in the post operative period and may prove superior
to the conventional Haemorrhoidectomy. The present study compares the efficiency of Katutumbi Bijadi Gudavarti with Apamarga Ksharasutra
Ligation in the patients of Arshas. |