| CTRI Number |
CTRI/2025/07/091378 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the effect of Tikshna Palasha Pratisarniya kshara and Drakshasava in Guda Arsha (II Degree Haemorrhoids) |
|
Scientific Title of Study
|
Clinical Evaluation of Tikshna Palasha Pratisarniya kshara along with Drakshasava in Guda Arsha (II Degree 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 |
Bhumika Mahendru |
| Designation |
PG SCHOLAR |
| Affiliation |
patanjali bhartiya ayurvigyan evum 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 |
7906459863 |
| Fax |
|
| Email |
bhumikamahendru015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Yadav |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
patanjali bhartiya ayurvigyan evum 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 |
9557692057 |
| Fax |
|
| Email |
drmanishayadav4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhumika Mahendru |
| Designation |
PG SCHOLAR |
| Affiliation |
patanjali bhartiya ayurvigyan evum 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 |
7906459863 |
| Fax |
|
| Email |
bhumikamahendru015@gmai.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, yogpeeth phase1 , Roorkee Road, Haridwar, Uttarakhand, India 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar |
| Address |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar, Uttarakhand 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 |
| Bhumika Mahendru |
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 |
7906459863
bhumikamahendru015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patanjali ayurvedic college |
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, (2) 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 | - | Tikshna Palasha pratisarniya kshara along with drakshasava in guda arsha (II degree haemorrhoids) | (Procedure Reference: sushrut samhita, Procedure details: Tiksha palasha pratisarniya kshara in guda arsha)
(1) Medicine Name: Drakshasava, Reference: yogratnakar, Route: Oral, Dosage Form: Asava, Dose: 40(ml), Frequency: bd, Duration: 3 Months |
|
|
|
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 and external haemorrhoids 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 of 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 and external piles.
3. patients with any other anorectal 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, crohns disease, cirrohosis of liver, diabetes mellitus, tuberculosis, and heart diseases will be excluded from this study.
5. patients with evidence of malignancy
6. HIV, Hepatitis b/c positive patients.
7. pregnancy
8. ulcerated haemorrhoids |
|
|
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.Constipation
2.Pain in anal region
3.Prolapse pile mass per rectum
4.bleeding per rectum |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proctoscopic evaluation of the pile mass-
1. site
2. size of pile mass
3. surface
4. position
|
3 months |
|
|
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)
|
11/08/2025 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 II degree haemorrhoids. Tikshna Palasha Pratisarniya kshara will be applied over pile masses under local anesthesia and drakshasava has been given orally to the patients and the conclusion will be made on the basis of observation which is done on subjective and objective parameters. |