| CTRI Number |
CTRI/2024/10/075879 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Apamarga pratisarniya kshara and Sariva pratisarniya kshara in Guda Arsha (Hemorrhoids) |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Apamarga Pratisarniya Kshara and Sariva Pratisarniya Kshara in Guda Arsha (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 |
Monu |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Address |
OPD 15, Department of Shalya Tantra, Patanjali ayurved hospital,
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase
1, Roorkee Road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8059199292 |
| Fax |
|
| Email |
monukaushik139@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sachin Gupta |
| Designation |
HOD & Professor |
| Affiliation |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan |
| Address |
OPD 15, Department of Shalya Tantra, Patanjali ayurved hospital,
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase
1, Roorkee Road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9419135050 |
| Fax |
|
| Email |
chintu.925@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monu |
| Designation |
PG Scholar |
| Affiliation |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan, Haridwar |
| Address |
OPD 15, Department of Shalya Tantra, Patanjali ayurved hospital,
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase
1, Roorkee Road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8059199292 |
| Fax |
|
| Email |
monukaushik139@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Yogpeeth phase-1, Roorkee Road,
Haridwar, Uttarakhand, India 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,
Haridwar, Uttarakhand, India 249405 |
| Type of Sponsor |
Private 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 |
| Dr Monu |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
OPD 15, Department of Shalya Tantra, Patanjali ayurved hospital,
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase
1, Roorkee Road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL |
8059199292
monukaushik139@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K648||Other hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Kshara karma with Apamarga pratisarniya kshara | (Procedure Reference: , Procedure details: The Apamarga Pratisarniya Kshara will be applied over the pile mass with the help of scoop under direct vision & wait for 100 Matra Kala (about 1 minute) until the sign & symptoms of Samyaka Dagdha “PakvajambuPhala†will be seen. After that Nimbu Swarasa in sufficient quantity will be used for washing of applied Kshara. Whole procedure will be performed in only one sitting & duration of treatment would be of 30 days.)
| | 2 | Intervention Arm | Procedure | - | Kshara karma with Sariva pratisarniya kshara | (Procedure Reference: , Procedure details: The Sariva Pratisarniya Kshara will be applied over the pile mass with the help of scoop under direct vision & wait for 100 Matra Kala (about 1 minute) until the sign & symptoms of Samyaka Dagdha “PakvajambuPhala†will be seen. After that Nimbu Swarasa in sufficient quantity will be used for washing of applied Kshara. Whole procedure will be performed in only one sitting & duration of treatment would be of 30 days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between 16 to 60 years of age.
2. The patients having complaints of I and II-degree internal hemorrhoids will be taken for the study after per rectal examination.
3. Patients willing to undergo trial and ready to give informed and written consent.
4. Patients of both sexes above the age 16 years. |
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 16 years and above the age of 60 years.
2. III- and IV-degree internal pile.
3. Patients with any other Ano-rectal disease, like Fistula-in-Ano, Fissure in Ano, Rectal prolapse will be excluded from this study.
4. Patients suffering from systemic diseases such as Ulcerative colitis, Crohn’s disease, Cirrhosis of liver, Diabetes mellitus, Tuberculosis and Heart disease will be excluded from this study.
5. Patients with Evidence of malignancy.
6. HIV, Hepatitis B/C positive patients.
7. Pregnancy.
8. Ulcerated hemorrhoids. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain in anal region
2. Prolapse pile mass per rectum
3. Bleeding per rectum
|
7Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proctoscopic evaluation of the pile mass-
1) Site
2) Surface
3) Position
4) Size of the pile mass |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/11/2024 |
| 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
|
In this study, we will take patients of hemorrhoids in two random group in 30 each. In first group, Sariva Pratisaraniya Kshara will be applied over pile masses under local anesthesia. In second group, Apamarga Pratisaraniya Kshara will be applied over pile masses under local anesthesia. Assessment will be done according to subjective and objective parameters mentioned above. |