| CTRI Number |
CTRI/2020/09/027765 [Registered on: 11/09/2020] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurveda management of Fissure in ano |
|
Scientific Title of Study
|
A study on effect of Prapoundrikadya Ghritta in the management of Parikartika w.s.r. Fissure in ano |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preeti |
| Designation |
MS Scholar |
| Affiliation |
Govt PG Ayurvedic College and Hospital Varanasi |
| Address |
Department of Shalya Tantra Govt PG Ayurvedic College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
8279887379 |
| Fax |
|
| Email |
preeti00519@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailendra |
| Designation |
Asst Prof |
| Affiliation |
Govt PG Ayurvedic College and Hospital Varanasi |
| Address |
OPD No 25 Department of Shalya Tantra Govt PG Ayurvedic College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
9935337085 |
| Fax |
|
| Email |
dr.shailendra.ent@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailendra |
| Designation |
Asst Prof |
| Affiliation |
Govt PG Ayurvedic College and Hospital Varanasi |
| Address |
OPD No 25 Department of Shalya Tantra Govt PG Ayurvedic College and Hospital Varanasi
UTTAR PRADESH
221001
India |
| Phone |
9935337085 |
| Fax |
|
| Email |
dr.shailendra.ent@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt PG Ayurvedic College and Hospital Chaukha Ghat Varanasi |
|
|
Primary Sponsor
|
| Name |
Govt PG Ayurvedic College and Hospital Varanasi |
| Address |
Chauka Ghat Govt PG Ayurvedic College and Hospital Varanasi |
| Type of Sponsor |
Other [Govt PG Ayurvedic College and Hospital] |
|
|
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 |
| Preeti |
Room no 202 Department of Shalya Tantra Govt PG Ayurvedic College and Hospital |
Ghauka ghat Govt PG Ayurvedic College and Hospital Varanasi
Varanasi
UTTAR PRADESH |
8279887379
preeti00519@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Jatayadi Ghrita |
In 30 patients Local application of Jatayadi Ghrita in wound of fissure in ano twice daily after hot sitz bath for time period of 28 days |
| Intervention |
Prapoundrikadya Ghrita |
In 30 Patients Local application of Prapoundrikadya Ghrita in wound of fissure in ano(Parikartika) twice daily after hot sitz bath for time period of 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients clinically diagnosed or confirmed by inspection as having Parikartika (acute fissure in ano) with a duration of less than 28 days
2 Patients of either sex religion and irrespective of demographic data
3 Age limitation between 18 to 60 yrs
4 Controlled cases of Hypertension and Diabetes mellitus
5 Willing and able to participate in the study
|
|
| ExclusionCriteria |
| Details |
1 Fissure in ano having duration more than 28 days
2 Patient having Parikartika (fissure in ano) secondary to Crohns disease Ulcerative colitis syphilis tuberculosis will be excluded
3 Patient having anal or perianal cancer
4 Patients with positive Viral markers
5 Fissure in ano associated with piles fistula in ano
6 Uncontrolled cases of Diabetes mellitus, Hypertension or any other condition in which the investigator thinks may jeopardize the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of Disease |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life |
3 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/09/2020 |
| Date of Study Completion (India) |
24/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
This clinical study will be published in indexed journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim to current study us to evaluate the comparative effect of Prapoundrikadya Ghritaand Jatayadi Ghrita in the management of Parikaritka( Fissure in ano). A total of 60 diagnosed patients will be randomly divided into 2 groups. In a group, A total of 30 patients will be treated with Prapoundrikadya Ghrita and in group B a total of 30 patients will be treated with Jatayadi Ghrita. In both, the groups’ patients daily dressing twice a day will be done for a time period of 28 days. After complition of therapy patient will be called on every 15 days for the next 2 months for follow-up. The assessment of therapy will be done after the completion of treatment. The result will be assessed with statical calculation. |