| CTRI Number |
CTRI/2025/08/093242 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An Ayurvedic management of Internal Haemorrhoids comparing with Ghoshaphala Varti and Ghoshaphala Vati |
|
Scientific Title of Study
|
A Comparitive Clinical Study to evaluate the effect of Ghoshaphala Varti and Ghoshaphala Vati in Arshas with Special Reference to Internal 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 Geetha N S |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre, Kuthpady , Udupi |
| Address |
Department of PG studies in Shalya Tantra
Shalya Tantra General OPD no.5
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre, Kuthpady , Udupi-574118
Udupi
KARNATAKA
574118
India |
| Phone |
9945650190 |
| Fax |
|
| Email |
msgeetha2023@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh R N |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre, Kuthpady , Udupi. |
| Address |
Department of PG studies in Shalya Tantra
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre, Kuthpady , Udupi.
Udupi
KARNATAKA
574118
India |
| Phone |
9449753320 |
| Fax |
|
| Email |
rakesharyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha N S |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre, Kuthpady , Udupi. |
| Address |
Department of PG studies in Shalya Tantra
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre, Kuthpady , Udupi.
Udupi
KARNATAKA
574118
India |
| Phone |
9945650190 |
| Fax |
|
| Email |
msgeetha2023@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Geetha N S
PG Scholar
Department of PG Studies in Shalya Tantra
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre, Kuthpady , Udupi. |
|
|
Primary Sponsor
|
| Name |
Dr Geetha N S |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre, Kuthpady , Udupi. |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR RAKESH R N |
SDM COLLEGE OF AYURVEDA , KUTHPADY UDUPI, 574118. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Geetha N S |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre |
Department of PG studies in Shalya Tantra
Shalya Tantra General OPD no 5 and IPD
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre, Kuthpady , Udupi 574118.
Udupi
KARNATAKA |
9945650190
msgeetha2023@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SDM College of Ayurveda , Kuthpady , Udupi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K640||First degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ghoshaphala varti, Reference: Chakradutta, Route: Rectal, Dosage Form: Gudpak, Dose: 2(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Ghoshaphala varti is inserted per rectally after lubricating with Ghrita(2) Medicine Name: Ghoshaphala vati, Reference: Chakradutta, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Ghoshaphala vati of 500mg given orally 2 TID |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with Arshas according to signs and symptoms explained in the classics, i.e.,
Vistamba (constipation)
Srava (Bleeding per anum)
toda (Pain)
kandu (Pruiritis Ani)
• Per rectal, Proctoscopic examination diagnosing Internal Hemorrhoids.
• Mucoid discharge per anum.
2. Subjects fulfilling diagnostic criteria who are willing to give informed consent and follow up the
protocol of the study.
3. Patients of either gender.
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from systemic diseases like uncontrolled Diabetes mellitus, Tuberculosis,
HIV, Hepatitis, bleeding disorders.
2. Patients who are on anticoagulant medications.
3. Pregnant women.
4. Patients having associated ano-rectal diseases like Polyp, Carcinoma rectum, Sentinel tag,
Fissure-in-Ano, Fistula-in-Ano.
5. Patients having internal hemorrhoids complications like strangulated, thrombosed, infected
internal hemorrhoids.
6. Patients below 16 years and above 70 years of age.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out the effect of Ghoshaphala varti and Ghoshaphala vati in Internal Haemorrhoids by observing changes in normalcy of stool consistency
and reduction in mucoid discharge,itching,bleeding per rectum |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemorrhoids severity score
Bristol stool chart
Degree of haemorrhoidal prolapse |
30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
09/09/2025 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Arshas1 is a disease afflicting mankind for thousands of years. It presents in the form of mamsa ankuras (fleshy masses) at the opening of gudamarga (anus) causing obstruction to the pathway. Arshas may be compared with hemorrhoids, which is dilation of hemorrhoidal plexus of veins situated in the lower portion of the rectum and in the sub epithelial region anal canal3 . Studies shows 4.4% of total world population is affected by hemorrhoids4 . Incidence rate is 47/1000 majorly in age group of 40-65 years. Males are more affected in comparison to females. The risk factors are low fiber diet, mixed diet, poor hydration, chronic constipation or diarrhoea, straining during defecation, low physical activity and obesity5 . Several surgical approaches have been introduced including hemorrhoidectomy but post operative pain is invariable. In such conditions conservative methods plays an essential role in preparing the patients for minimally invasive treatments. Bheshaja chikitsa6 is mentioned as first line of treatment for uncomplicated, recent origin, minimally manifested arshas . It has major role as it is safe and easy to apply. Bheshaja chikitsa is classified into bahya and abhyantara . Medicines can be used Externally or internally in various forms. Among them, Varti is effective as stanika chikitsa which is administered per rectally where drugs is released constantly in guda pradesha.Therefore, this study aims to evaluate the therapeutic effect of Ghoshaphala varti to address the persistent demand for safer and more efficacious interventions in internal haemorrhoids of Grade I and Grade II. |