| CTRI Number |
CTRI/2025/06/089255 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| 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 study to know the effect of Yava Kshara Sutra ligation in the treatment of Arshas (Piles/Haemorrhoids) |
|
Scientific Title of Study
|
A controlled clinical study to evaluate the efficacy of Yava Kshara Sutra Trans-ligation in the management of Arshas (3rd & 4th 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 |
Dr Abhinav Sharma |
| Designation |
Second year Pg scholar |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
| Address |
Department of post-graduation studies in Shalya Tantra,Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal
Koppal KARNATAKA 583231 India |
| Phone |
08618726170 |
| Fax |
|
| Email |
abhin12390@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mahantesh M Salimath |
| Designation |
Professor |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
| Address |
Department of post-graduation studies in Shalya Tantra,Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal
Koppal KARNATAKA 583231 India |
| Phone |
9845010950 |
| Fax |
|
| Email |
dr_mahantesh@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mahantesh M Salimath |
| Designation |
Professor |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
| Address |
Department of post-graduation studies in Shalya Tantra,Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal
Koppal KARNATAKA 583231 India |
| Phone |
9845010950 |
| Fax |
|
| Email |
dr_mahantesh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room No.16 Department of post-graduation studies in Shalya Tantra,Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Gavimata, Koppal, Karnataka, INDIA.
PIN:583231 |
|
|
Primary Sponsor
|
| Name |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal |
| Address |
Room No16, Department of Post Graduation studies in shalya tantra ,Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal, Karnataka, INDIA PIN:583231 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Abhinav Sharma |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
Department of post-graduation studies in Shalya Tantra,Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal Koppal KARNATAKA |
8618726170
abhin12390@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Hospital Post Graduate Studies and Research Centre Koppal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K643||Fourth degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Trans-Ligation of arshas by YavakShArasUtra, क्षारसूत्र | (Procedure Reference: Sushrut Samhita, Nibandha Sangraha Commentary of Shri Dalhanacharya edited by Vaidya Yadavaji Trikamji Acharya, Varanasi, Chaukambha Sanskrit Sansthana Reprint 2013, Chikitsasthana Chapter no.6, Shloka no.3, page no.430, Procedure details: Surgical procedure of trans ligation of arshas(3rd & 4th degree haemorrhoids) with yava kshara sutra on DAY 1)
| | 2 | Comparator Arm | Procedure | - | Trans-Ligation of arshas by Apamarga kShAra sUtra, क्षारसूत्र | (Procedure Reference: Sushrut Samhita, Nibandha Sangraha Commentary of Shri Dalhanacharya edited by Vaidya Yadavaji Trikamji Acharya, Varanasi, Chaukambha Sanskrit Sansthana Reprint 2013, Chikitsasthana Chapter no.6, Shloka no.3, page no.430, Procedure details: surgical procedure of trans liagation of Arshas (3rd & 4th degree hemorrhoids) by Apamarga Kshara Sutra)
|
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient of either gender aged between 20-65 years diagnosed with Arsha (3rd & 4th degree Hemorrhoids). |
|
| ExclusionCriteria |
| Details |
1st and 2nd degree Hemorrhoids
Hemorrhoids associated with other fistula in ano fissure in ano rectal prolapse rectal carcinoma ano rectal abscess ulcerative colitis crohns disease portal hypertension tuberculosis
systemic illness like diabetes mellitus hypertension
HIV HCV AND HbsAg positive patients
|
|
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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 |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Yava Kshara Sutra in terms of days taken by kshara sutra to slough out the pile mass |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Apamarga Kshara Sutra is having more efficacy than Yava Kshara Sutra in the management Arshas(3rd & 4th degree Haemorrhoids). |
7 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 4 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="0" Months="10" Days="10" |
|
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
|
Hemorrhoids are the pedicle like lesions formed by dilated radicles of the superior, middle and inferior rectal veins in the subepithelial region of the anal canal. Internal Haemorrhoids occur within the anal canal and External Hemorrhoids are situated outside the anal orifice. These even co-exist as Interno-External Haemorrhoids. 1 The incidence of this disease is showing augmentation with advancing age equally in both males and females. At least 50% of the people over the age of 50 years have some degree of symptoms related to hemorrhoids.3 The prevalence rate of piles is 4.4% in the world, in about 10 million people. Haemorrhoids may occur at any age but mostly seen in the age between 30 to 65 years.4 According to prolapse haemorrhoids are classified into 4 degrees wherein 3rd degree haemorrhoids come out during defecation and do not return by themselves but need to be placed back manually and 4th degree haemorrhoids are permanently prolapsed and are characterized by a great deal of discomfort and heaviness in the rectum. Bleeding, prolapse, pain, discharge and anaemia are the common clinical features. 5 Modern therapeutic management for 3rd & 4th degree Hemorrhoids includes Lord’s dilatation, Cryosurgery, Infra-red coagulation, laser therapy, DGHAL (Doppler Guided Hemorrhoidal Artery Ligation), open-Haemorrhoidectomy, closed-haemorrhoidectomy, and Stapled Haemorrhoidopexy 6 which have their own disadvantages such as starting of profuse watery discharge within 3 hours of Cryosurgery which lasts upto 3 to 4 weeks, significant incidences of incontinence in elderly after Anal dilatation, marked stenosis of anal canal after complete removal of haemorrhoidal mass during Closed Haemorrhoidectomy.7 This shows inadequacy of modern science to provide complete relief in terms of effective management of haemorrhoids. Haemorrhoids are rationally correlated to Arshas. According to Acharya Vagbhata, Arshas are the mamsankura (engorged veins) protruding out and obstructing the Guda marga (Anal Canal) which tortures the person like an enemy 2. Acharya Sushruta has mentioned six types of Arshas they are vataja, pittaja, kaphaja, raktaja, sannipataja and Sahaja. Arshas are associated with clinical features such as Mamsankura in guda, Shula, Vedana, Rakta atisrava, daha, Guda kandu, shopha8. Treatment modality for the management of Arshas 9 as advised in Sushruta Samhita are Bheshaj Chikitsa , Kshara Karma, Agnikarma and Shastra Karma .Among these Kshara karma in Arshachikitsa has been adviced in Arshas which are mrudu(soft), Prasruta(broad), Avagadha(deep seated) and Uchrita(bulged up) .10 The use of Kshara is considered effective in management of piles in terms of least complications as it is minimally invasive and better economic suitability as it eliminates the requirement of hospital stay. Apamarga(Achyranthes aspera) is one such drug which has been used to prepare Kshara and has proven effective in the management of ano-rectal disorders. Exploration of the new Herbal drugs for the preparation of Kshara is the need of the hour as aparmarga is limited by its seasonal availability. According to Acharya Sharangdhara 11 Yava (Hordeum Vulgare Linn.) is one of the Kshara Dravya which is well known for its lekhana property as told in the context of management of Arshas, has been selected as the choice of drug in this study for making of Kshara Sutra, to find out an effective alternative to Apamarga Kshara Sutra in view of its better seasonal availability, effectiveness of cost and ease of accessibility. An attempt is made to check the efficacy of Yava Kshara Sutra over Apamarga Kshara Sutra in the management of Arshas (3rd & 4th degree Haemorrhoids). |