| CTRI Number |
CTRI/2024/08/073156 [Registered on: 30/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Rectal suppository] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Insertion of Ghoshaphalvarti as Rectal Suppository in the management of 2 Degree Internal Haemorrhoids |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial to Evaluate the Efficacy of Ghoshaphalvarti as arshoghna in the management of Arsha (2 Degree 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 |
DrBhakti Rambhau Shewale |
| Designation |
MD Scholar Shalyatantra Department |
| Affiliation |
CSMSS Ayurved College kanchanwadi, Chhatrapati Sambhajingar Department of Shalyatantra opd no-16 |
| Address |
Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya & Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9405524328 |
| Fax |
|
| Email |
bhaktishewale30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Nivruttirao Gundre |
| Designation |
Professor |
| Affiliation |
CSMSS Ayurved College kanchanwadi, Chhatrapati Sambhajingar Department of Shalyatantra , opd no-16 |
| Address |
Department of Shalyatantra Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya & Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9518548733 |
| Fax |
|
| Email |
rgundre200@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhakti Rambhau Shewale |
| Designation |
PG SCHOLAR |
| Affiliation |
CSMSS Ayurved College kanchanwadi, Chhatrapati Sambhajingar |
| Address |
Department of Shalyatantra Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya & Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9405524328 |
| Fax |
|
| Email |
bhaktishewale30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya & Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar
Aurangabad
Maharashtra
India
431011 |
|
|
Primary Sponsor
|
| Name |
CSMSS Ayurved College Kanchanwadi Chhatrapati Sambhajinagar |
| Address |
Department of Shalyatantra CSMSSS Ayurved mahavidyalaya and rugnalaya
Kanchanwadi,Chhatrapati
Sambhajinagar
Maharashtra
India
431011
Maharashtra
India
431011 |
| Type of Sponsor |
Other [self ] |
|
|
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 Bhakti Rambhau Shewale |
C.S.M.S.S Ayurved Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar |
OPD NO- 16 Shalyatantra department of Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya & Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar
431011
Aurangabad
MAHARASHTRA |
9405524328
bhaktishewale30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CSMSS Ayurved College and Hospital Kanchanwadi,Chhatrapati Sambhajinagar |
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 | Intervention Arm | Procedure | - | Gudvarti Insertion | (Procedure Reference: Sharangdhar samhita 3.19/7, Procedure details: 1) Under all aseptic precaution cleaning and draping will be done.
2) Give left lateral/lithotomy position to the patient.
3)Oil will be applied on varti for lubrication.
4)YAV SHAPED varti will be inserted slowly in Rectum.)
(1) Medicine Name: Ghoshaphalvarti, Reference: Bhaishajyaratnawali-9/8, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 7(g), Frequency: od, Duration: 1 Weeks | | 2 | Comparator Arm | Procedure | - | Tailpichu | (Procedure Reference: Sharangdhar samhita 9/142-14, Procedure details: 1) Under all aseptic precaution cleaning and draping will be done.
2) Give left lateral/lithotomy position to the patient.
3)Kasisadi Oil will be applied on gauze piece.
4)Pichu will be kept inside the Rectum.)
(1) Medicine Name: Kasisaditail, Reference: Sharangdhar samhita 9/142-14, Route: Rectal, Dosage Form: Taila, Dose: 7(ml), Frequency: od, Duration: 1 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having 2nd degree Haemorrhoids
patient having Age 20-60 years
selection of Patients will be done irrespective of sex, religion & socioeconomic class. |
|
| ExclusionCriteria |
| Details |
Patient having 3rd and 4th Degree Haemorrhoids
patient having CA Rectum & Anal Canal
Pregnancy.
patient having DM, HTN, HIV, HBsAg, Tuberculosis & any other Systemic Disorder. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bleeding, constipation, Size of Arshankur reduces on 1st,3rd,5th and 7th day |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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
|
The worldwide Prevalence rate of Hemorrhoids is 4.4%. It is a Common Ano-Rectal disease that is gradually increasing due to an Unhealthy Diet & sedentary Lifestyle etc. Rectal Supossitory is one of the important modalities to be used in the initial phases. Varti Kalpana is one of the important modalities to be used in the initial phases. In the Initial phases i.e. (I & II-degree Haemorrhoids) are treated with the help of conservative management and other surgical modalities are to be avoided. Varti Prayog comes under Shashti Upakrama having local action in Arshas. For those patients who do not respond to oral medicinal treatment the local treatments deserve its importance in them. Local treatment also gives immediate relief when it is combined with conservative treatment. Local resources are simple in technique with minimum complication and Easily managable. The study will be conducted on 92 diagnosed patients with 2-degree internal hemorrhoid written consent, initial assessment the patient will be divided into 2 groups Trial Group-A-Ghoshaphalvarti Control Group-B- Kasisaditailvarti observations and results will be noted Discussion and Conclusion
|