| CTRI Number |
CTRI/2025/01/079713 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| 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
|
To Study Efficacy of the Bibhitaka Pratisarniya Kshara in the treatment of Piles |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY EFFICACY OF BIBHITAKA PRATISARNIYA KSHARA IN THE MANAGEMENT OF ARSHA WITH SPECIAL REFERENCE TO 1st AND 2nd DEGREE INTERNAL HEMORRHOIDS |
| 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 Priyanka Parmeshwar Garje |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
Vidarbha Ayurved Mahavidhyala Dastur Nagar Amravati Maharashtra India |
| Address |
PG Quarter Room No 1 Vidarbha Ayurved Mahavidhyala Dastur Nagar Amravati Maharashtra India 444606
Amravati
MAHARASHTRA
444606
India |
| Phone |
9404321851 |
| Fax |
|
| Email |
priyagarje207@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjusha Shushil Kalmegh |
| Designation |
HOD and Associate Professor Shalyatantra Department Amravati |
| Affiliation |
Opd no 22 shalyatantra department Vidarbha Ayurved Mahavidhyala dastur nagar Amravati maharashtra india 444606 |
| Address |
Opd no 22 Shalyatantra department of Vidarbha Ayurved Mahavidhyala Dastur Nagar Amravati maharashtra india 444606
Amravati
MAHARASHTRA
444606
India |
| Phone |
9422155851 |
| Fax |
|
| Email |
manjushakalmegh75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Parmeshwar Garje |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
Pg quarter Vidarbha Ayurved Mahavidhyala Amravati maharashtra india 444606 |
| Address |
Pg quarter room no 1 Vidarbha Ayurved Mahavidhyala Dastur Nagar Amravati maharashtra india 444606
Amravati
MAHARASHTRA
444606
India |
| Phone |
9404321851 |
| Fax |
|
| Email |
priyagarje207@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd no.22 shalyatantra department vidarbha ayurvedic mahavidyalaya amravati maharashtra india maharashtra india 444606 |
| Opd no.22 shalyatantra department vidarbha ayurvedic mahavidyalaya dastur nagar amravati maharashtra india 444606 |
|
Primary Sponsor
Modification(s)
|
| Name |
Dr Priyanka Parmeshwar Garje |
| Address |
PG Quarter,Room number 4, Vidarbha Ayurved Mahavidhyala Dastur Nagar Amravati |
| Type of Sponsor |
Other [OPD patients of Vidarbha Ayurved Mahavidyalaya Amravati ] |
|
|
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 Priyanka Parmeshwar Garje |
Vidarbha Ayurved Mahavidhyala Amravati |
OPD Number 22 Shalyatantra Department Amravati
Amravati
MAHARASHTRA |
9404321851
priyagarje207@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Vidharbha Ayurved Mahavidyala Amravati |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Apamarg kshar, Reference: Sushrut sutra, Route: Topical, Dosage Form: Kshara , Dose: 1(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bibhitak , Reference: Sushrut sutrasthan, Route: Topical, Dosage Form: Kshara , Dose: 1(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Application of apamarg kshar over piles |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of 1st and 2nd degree internal hemorrhoids
Those who are ready to give informed consent and to be part of study
Age group of 20-60 year
Selection of the patients will be done irrespective of religion,gender and socioeconomic status |
|
| ExclusionCriteria |
| Details |
Those patients who are not willing to give consent
Patients of known case of CA rectum, any systemic diseases like uncontrolled HTN,DM
Patients with 3rd and 4th degree internal hemorrhoids
Hemorrhoids thar are thrombosed,prolapsed and bleeding
Patients below age 20 and above 60 years are excluded
|
|
|
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 |
| Bhibhitaka Pratisarniya Kshara is significant in treatment Arsha with special reference to 1st and 2 nd degree hemorrhoids |
0th day
7th day
14th day
21th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Study the literature of Arsha according to Ayurveda and Modern science
To study literature of Pratisarniya Kshara
To prepare Bhibhitaka Pratisarniya Kshara
To study Discoloration,Raktasrava and Shula criteria
To observe the side effects if any |
Assessment on
0th day
7th day
14th day
21 th day
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
07/02/2025 |
| 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="6"
Days="0" |
|
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)?
|
|
Brief Summary
|
The current study is a Randomised Control parallel group Clinical Trial for studying the effect of Bhibhitaka Pratisarniya Kshara along with Yastimadhu Ghrita application for 14 days. Patients diagnosed with 1st and 2nd degree internal hemorrhoids will be divided into 2 groups equally namely experimental and control group. Bhibhitaka Kshara application done once and Yastimadhu Ghrita application locally twice a day for seven days will be given to experimental group and Apamarg Kshara will be applied to control group. Assessment will be done at 0th 7th 14th day.In todays lifestyle, many patient refuses for surgical treatment because of its postoperative complication, Ksharkarma is substitute of surgical instruments because they can be used safely on the patient who afraid of surgery.Kshar Pratisaran means application of Kshar locally. This procedure is less invasive and gives very less unwanted side effects like bleeding, burning sensation. Acharya Sushruta has described Kshar Pratisaran in the treatment of Arsha in Sushruta Arshachikitsa Adhaya 6/12.Arka Kshar and Apamarga Kshara are used for Pratisaran but there are many drugs which has to prove its efficacy in the treatment of Arsha. Amongest them one is Bibhitaka. In previous trial Arka Kshar has proven its efficacy in comparison with Apamarg Kshar so in this study sincere efforts will be made to check the efficacy of Bibhitaka Kshar Pratisaran. |