| CTRI Number |
CTRI/2025/05/086764 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| 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
|
Efficacy of Peelu Tail Pichu in 1st and 2nd Degree Internal Haemorrhoids |
|
Scientific Title of Study
|
Randomised Clinical Trial to evaluate the Efficacy of Peelu Tail Pichu in 1st and 2nd Degree 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 |
Jobanjeet kaur |
| Designation |
PG Scholar Department of Shalya Tantra (Gen Surgery Ayu) |
| Affiliation |
Department of Shalya Tantra Sri Sai Ayurvedic PG medical College and Hospital , Aligarh |
| Address |
Department of Shalya Tantra (Gen Surgery Ayu)
Sri Sai Ayurvedic PG Medical College and Hospital , Sarsol , Phal Mandi
Aligarh
U.P
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9780342925 |
| Fax |
|
| Email |
jobanrandhawa1195@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupinder |
| Designation |
Professor Department of Shalya Tantra |
| Affiliation |
Sri Sai Ayurvedic PG Medical College and Hospital, Aligarh |
| Address |
Department of Shalya Tantra (Gen Surgery Ayu)
Sri Sai Ayurvedic PG medical College and Hospital , Sarsol
Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9996247919 |
| Fax |
|
| Email |
dr.bhupindersaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupinder |
| Designation |
Professor Department of Shalya Tantra |
| Affiliation |
Sri Sai Ayurvedic PG Medical College and Hospital, Aligarh |
| Address |
Department of Shalya Tantra
Sri Sai Ayurvedic PG medical College and Hospital , Sarsol
Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9996247919 |
| Fax |
|
| Email |
dr.bhupindersaini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jobanjeet kaur |
| Address |
Sri Sai Ayurvedic PG medical college and Hospital,Aligarh Pincode 202001
State UP , India. |
| Type of Sponsor |
Other [SELF] |
|
|
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 Jobanjeet Kaur |
Sri Sai Ayurvedic PG medical college and Hospital |
Department of Shalya Tantra,
Sri Sai Ayurvedic PG medical College and Hospital
Sarsol,
Aligarh 202001
U.P
Aligarh
UTTAR PRADESH |
9780342925
jobanrandhawa1195@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Sri Sai Ayurvedic PG Medical College and Hospital |
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: Peelu Tail (oil of salvadora Persica), Reference: Sushruta Sutra Asthana 46/194, Bhav Parkash Nighantu Phalvarga,Raj Nighantu karviradi Varga, , Route: Rectal, Dosage Form: Taila, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Madhyabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Annovate Cream, Reference: NA, Route: Rectal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Madhyabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with 1st and 2nd Degree Internal Haemorrhoids selected. |
|
| ExclusionCriteria |
| Details |
1. Patients of age group less than 18 and more than 75 years.
2. 3rd and 4th degree prolapsed Internal Haemorrhoids
3. Patient suffering from haemorrhoids with malignancy, ulcerative colitis, Crohn’s
disease, liver disorder .
4. Other anorectal conditions for example fissure, fistula,
constipation
5. Pregnancy
6. HIV or HBsAg positive patients
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Criteria:
1 Pile Mass
2.Bleeding Per Rectum
3.Number Of Pile Mass
4.Itching
OBJECTIVE CRITERIA
1. Proctoscopy before and after photos of pile mass |
0,7th , 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2025 |
| 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="0"
Months="10"
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)?
Response - NO
|
|
Brief Summary
|
Arsha (Haemorrhoids) is one of the
commonest diseases encountered in clinical and surgical practice. Acharya
Sushruta included it in Ashta Mahagada showing the severity of disease. In
modern science, there is no specific treatment for it. Surgical procedures of
Haemorrhoids also had drawbacks like recurrence, infection, anal stricture,
pain and discomfort to patients, formations of ulceration at anal canal.
Hence there is a need to search an alternative Ayurvedic medicine with less
cost and more effectiveness in bleeding piles. In this present era a greater
number of patients are interested to take Ayurvedic medicine. Henceforth to
evaluate the efficacy of Peelu Tail Pichu in 1st and 2 nd Degree haemorrhoids this study is done.
|