| CTRI Number |
CTRI/2025/05/087649 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
using ARIHAR SUPPOSITORY for treating Grade 2 internal haemorrhoid |
|
Scientific Title of Study
|
A Clinical study to evaluate the role of Arihar suppository locally along with the Diet and Lifestyle Modification in the Management of Abhyantar Arsh Grade 2 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 Vedika Bhoir |
| Designation |
Associate professor |
| Affiliation |
D.Y. Patil deemed to be university, School of Ayurveda, Nerul, Navi Mumbai |
| Address |
3rd floor, Department of Shalyatantra, D.Y.Patil School of Ayurveda deemed to be university Nerul Navi mumbai400706
D.Y.Patil School of Ayurveda deemed to be university Nerul
Thane
MAHARASHTRA
400706
India |
| Phone |
9029112333 |
| Fax |
|
| Email |
vedika.bhoir@dypatil.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshana Ishi |
| Designation |
P.G Scholar |
| Affiliation |
D.Y. Patil deemed to be university, School of Ayurveda Nerul Navi Mumbai |
| Address |
3rd floor, Department of Shalyatantra D.Y.Patil School of Ayurveda deemed to be university Nerul Navi Mumbai 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9370446866 |
| Fax |
|
| Email |
darshanaishi944@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vedika Bhoir |
| Designation |
Associate Professor |
| Affiliation |
D.Y. Patil deemed to be university, School of Ayurveda Nerul Navi Mumbai |
| Address |
3rd floor, Department of Shalyatntra, D.Y.Patil School of Ayurveda deemed to be university Nerul Navi mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9029112333 |
| Fax |
|
| Email |
vedika.bhoir@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| Opd no 3, 1st Floor, D.Y.Patil School Ayurveda, Nerul, Navi Mumbai District - Thane Maharashtra, India, pin-400706 |
|
|
Primary Sponsor
|
| Name |
Darshana Sudhir Ishi |
| Address |
D.Y.Patil School of Ayurveda deemed to be university Nerul Navi mumbai |
| 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 Darshana Ishi |
D.Y.Patil Ayurvedic hospital |
1st Floor Shalyatantra OPD
No 3 D Y Patil Ayurvedic Hospital Nerul Navi Mumbai
Thane
MAHARASHTRA |
09370446866
darshanaishi944@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee D.Y.PATIL school of Ayurveda Navi mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ARSAH, (2) 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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ARIHAR SUPPOSITORY, Reference: CHARAK CHIKITSA, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Thrice daily for Local application 15 days in morning after defecation , in afternooon and in night before sleeping hours.
|
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis will be done with the help of sigmoidoscope/video proctoscope & patient of second-degree internal haemorrhoids will be included in this study.
-All cases will be fresh/new
- age group of 18 to 60 yrs irrespective of their gender and religion, occupation, education , socio -economical status.
|
|
| ExclusionCriteria |
| Details |
-grade 3 and grade internal haemorrhoid, thrombose pile, fissure in Ano
-patient with uncontrolled systemic disease like DM, HTN, Bleeding disorder like haemophilia.
-post operated patients, pregnant women,
|
|
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Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
TO EVALUATE THE ROLE OF ‘ARIHAR SUPPOSITORY (LOCALLY)’ ALONG WITH DIET AND LIFESTYLE MODIFICATION IN THE MANAGEMENT OF ABHYANTAR ARASHA (GRADE II INTERNAL HAEMORRHOIDS).
|
Treatment will be given for 1 month and assessment will be done on 1,3,5,7,14,21,28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of ARIHAR SUPPOSITORY (locally) in the management of symptoms of Abhyantara arsha such as Bleeding P/R, Size of Pedicle, Colour of Pedicle, Constipation. |
the assessment will be done on 1,3,5,7,14,21,28 days for the treatment |
To establish ARIHAR SUPPOSITORY As local treatment & user friendly for arsha ie to grade 2 internal haemorrhoids.
|
after observation of the treatment given for 28 days in 50 patients |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
31/05/2025 |
| 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
|
Haemorrhoids are masses or lumps formed by abnormal dilatation and distortion of the vascular channel .Haemorroid is one of the major type of anorectal disease.Heam means blood rhoos means flowering. Heamorrhoid also called as piles which means mass or ball .Life style modification, improper dietary habits, constipation are precipatiting factors for Heamorrhoids.There are two types of heamorrhoids depending on the position of varicosity.If it is above the hilton’s line then called as internal Heamorroids. If it is below the hilton’s line then called as external Heamorroids.Internal heamorrhoids are typically cause prolapse or painless rectal bleeding Grade 2- Heamorrhoid prolapse upon defecation but spontaniously reduced .Acharya Sushruta has explained use of lepa Kalpana. Arihar suppository is 100% organic and Ayurvedic varti formulation .Arihar suppository is having drugs such as- lajjalu, yashtimadhu, .ghrita,.During 16th century ,lajjalu was popular herb for treating pile with properties of Sandhaniya, vrana ropak shodhak kledaghna arshogna, shoolopahar strotoshodhak.Yashtimadhu having property of vrana ropak ,shothhar,balya,.Ghrita having property of agnidipan, ayushya, balya,vata –pitta prashamana..Supporitory formulation with these ingredients will helps to reduce heamorhhoidal bleeding, and inflammation.
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