| CTRI Number |
CTRI/2024/11/076586 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Marichadi Modaka(drug) in the management of Arsha ( Internal haemorrhoids) |
|
Scientific Title of Study
|
A clinical Study to evaluate the efficacy of Marichadi Modaka on Arsha w.s.r. 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 Sagar Verma |
| Designation |
MS PG Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research center, Gangoh, Saharanpur |
| Address |
OPD no 3 Department of Shalya Tantra Kunwar Shekhar Vijendra
Ayurved Medical College and Research center Shobhit University
Gangoh, Saharanpur
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9759800984 |
| Fax |
|
| Email |
Sagarana09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra Singh Shekhawat |
| Designation |
MS Ayurveda Associate Professor department of Shalya Tantra |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research center, Gangoh, Saharanpur |
| Address |
OPD no 3 Department of Shalya Tantra Kunwar Shekhar Vijendra
Ayurved Medical College and Research center Shobhit University
Gangoh, Saharanpur
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9928297691 |
| Fax |
|
| Email |
dr.naren90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narendra Singh Shekhawat |
| Designation |
MS Ayurveda Associate Professor department of Shalya Tantra |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research center, Gangoh, Saharanpur |
| Address |
OPD no 3 Department of Shalya Tantra Kunwar Shekhar Vijendra
Ayurved Medical College and Research center Shobhit University
Gangoh, Saharanpur
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9928297691 |
| Fax |
|
| Email |
dr.naren90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kunwar Shekhar Vijendra Ayurved Medical College and Research center,Gangoh, Saharanpur,Uttar Pradesh,247341 |
|
|
Primary Sponsor
|
| Name |
Dr Sagar Verma |
| Address |
OPD no 3 Department of Shalya Tantra Kunwar Shekhar Vijendra
Ayurved Medical College and Research centre Shobhit University,
Gangoh, Uttar Pradesh,247341 |
| 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 Sagar Verma |
Kunwar Shekhar Vijendra Ayurved hospital and Research center |
OPD no 3 Department of Shalya Tantra Kunwar Shekhar Vijendra
Ayurved medical college and Research centre Shobhit University,
Gangoh, Uttar Pradesh,247341
Saharanpur
UTTAR PRADESH |
9759800984
Sagarana09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kunwar Shekhar Vijendra Ayurved Medical College and Research Center, Gangoh, Saharanpur, Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K649||Unspecified hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Marichadi Modaka , Reference: Yogaratnakar chapter no 5 shlok no 40, Route: Oral, Dosage Form: Modaka , Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Not any |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18 to 80 years.
Diagnosed pateint of 1st and 2nd degree internal haemorrhoids.
Pateints presenting with symptoms of Arshas mentioned in classical texts.
Ano-rectal Arsha only.
Piles mass seen by proctoscopy.
|
|
| ExclusionCriteria |
| Details |
Pateint with pittaj Prakriti.
The arsha developed due to portal hypertension, incontinence of stool,or due to secondary factors.
The pateints suffering from external haemorrhoids and conditions like thrombosis, ulcerative colitis and strangulated haemorrhoids will also be excluded from the study.
Patients having tuberculosis/Diabetes/Systemic disease,malignancies,HIV,HbsAg and VDRL positive.
3rd and 4th degree.
Bleeding diathesis, Menstruating women, multiple or external haemorrhoids. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms of Arsha like vibandha,guda kandu, guda shoola. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relieve in others symptoms of arsha like color of pile mass and degree of pile mass. |
After analysing all the parameters the result will
be assessed on the basis of symptomatic relief
and improvement.
Partially improvement after 7 days- patients get
40-60 percent relief from sign and symptoms.
Improvement after 14 days- patient get 60-80
percent relief from sign and symptoms.
Cured after 21 days- Patient get 80-100 percent
relief from sign and symptoms. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
16/11/2024 |
| 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="0"
Months="10"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Arsha can be included as one of the lifestyle disorders caused due to sedentary lifestyle. The arsha is one among the ano-rectal disease which occurs in Gudapradesh(anus) as Sadhyopranahara marma. Acharya Sushruta has mentioned several methods of treatment. Among them Bheshaja karma is the first line of treatment so Marichadi Modaka is indicated for the treatment. Therefore I have selected this trial, there will be 30 patients aged between 18 to 80 years, the patients should be selected on the basis of inclusion and exclusion criteria. The trial will be of 21 days, during trial assessment will be 0, 10th and 21st days. After trial follow up will be done after 28th, 35th,40th days after cessation of procedure. |