| CTRI Number |
CTRI/2020/05/024974 [Registered on: 01/05/2020] Trial Registered Prospectively |
| Last Modified On: |
21/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Apamarga and Arka Kshar-Lepa in Arsha(Haemorrhoids) |
|
Scientific Title of Study
|
Comparitive Study of Apamarga and Arka Pratisarniya Kshar-Lepa in Arsha(IInd Degree Haemorrhoids) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poornima Yadav |
| Designation |
P.G.Scholar |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
Department of Shalya tantra,Room no-07,Rishikul Campus Haridwar,Utterakhand Ayurveda University
Department of Shalya tantra ,Room no-07 Rishikul Campus Haridwar,Utterakhand Ayurveda University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8791427280 |
| Fax |
|
| Email |
ms.poornimayadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVishal verma |
| Designation |
professor |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
Department of Shalya tantra Room no 07 Rishikul Campus Haridwar Utterakhand Ayurveda University
Department of Shalya tantra Room no 07 Rishikul Campus Haridwar Utterakhand Ayurveda University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9719314634 |
| Fax |
|
| Email |
vishalverma100@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poornima Yadav |
| Designation |
P.G.Scholar |
| Affiliation |
Rshikul Campus Haridwar |
| Address |
Department of Shalya tantra Room no 07 Rishikul ayurvedic college Haridwar Uttarakhand
Department of Shalya tantra Room no 07 Rishikul ayurvedic college Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8791427280 |
| Fax |
|
| Email |
ms.poornimayadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalya tantra Room no 07 Rishikul campus Haridwar Uttarakhand Ayurvedic University |
|
|
Primary Sponsor
|
| Name |
Utterakhand ayurvedic university |
| Address |
Rishikul Campus Haridwar,Utterakhand Ayurvedic University Haridwar |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Poornima Yadav |
Rishikul Campus Haridwar |
Department of Shalya tantra Room no 07
Hardwar
UTTARANCHAL |
8791427280
ms.poornimayadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K641||Second degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Apamarga and Arka Pratisarniya kshar lepa on IInd degree Haemorrhoids |
Apamarga kshar lepa will be locally applied on each pile mass according to its size with the protection of normal mucosa and the process will be repeated at the interval of 7 days until the size of pile mass is reduced and same therapy will be done for the next 18 no of the patient having IInd degree internal haemorrhoids and will locally apply Arka kshar lepa on each pile mass according to its size at the interval of 7 days until the size of pile mass is reduce. |
| Comparator Agent |
Comparitive study of Apamarga and Arka Pratisarniya kshar lepa on Arsha(IInd degree Haemorrhoids) |
Apamarga kshar lepa will be locally applied on each pile mass according to its size with the protection of normal mucosa and the process will be repeated at the interval of 7 days until the size of pile mass is reduced and same therapy will be done for the next 18 no of the patient having internal haemorrhoids and will locally apply Arka kshar lepa on each pile mass according to its size at the interval of 7 days and then compare results of both kshar lepa application. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Having internal piles of IInd degree. |
|
| ExclusionCriteria |
| Details |
3rd and 4th Degree of Haemorrhoids
Arsha associated with other conditions like CA Rectum Rectal Prolapse and fistula in ano
Hepatitis B
HIV
HCV and VDRL
Secondary Arsha associated with other conditions like Ulcerative colitis and Crohns disease
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Recovery from the symptoms.
Reduction in the size of pile mass. |
2 month maximum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Recovery from the symptoms.
Reduction in the size of pile mass. |
2 month maximum |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 1 |
|
Date of First Enrollment (India)
|
04/05/2020 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Arsha (hemorrhoids) can be included as one of the lifestyle disorder caused due to sedentary lifestyle. Haemorrhoids also called as piles, are clumps of dilated veins in the anus and lower rectum. These become swollen and inflamed causing pain and rectal bleeding while defecation. Acharya Sushruta has basically mentioned four types of treatments, i.e., Bheshaja, Ksharakarma, Agnikarma and Shastrakarma for Arsha . As per the available treatment modalities of Arsha, the Kshara karma modality is the best one, taking into the consideration its convenience, easy adaptability, cost-effectiveness and curative results. both the kshara will be prepared as per the standard method described in Ayurvedic texts. Under this parasurgical procedure, Pratisarniya kshara -Lepa will be used in treating the Arsha (IInd degree Haemorrhoids) , according to degree of pile mass and different signs and symptoms. In this present study, we compare the effect of Apamarga and Arka kshara-Lepa in Arsha (IInd degree haemorrhoids) After the apllication of kshar -Lepa , their may occure reduction in size,and relief in symptoms beucause of its chedana(excision), Bhedan(incision) Lekhana(scraping) and Tridoshagna properties .Lastly, we will be assuming that kshar - Lepa show significant improvement in 2nd degree of pile masses without any side effect. |