| CTRI Number |
CTRI/2021/10/037202 [Registered on: 08/10/2021] Trial Registered Prospectively |
| Last Modified On: |
04/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study the role of Durvadi tail matra basti in Parikartika with special reference to Fissure in Ano. |
|
Scientific Title of Study
|
Randomized open controlled Clinical study on the role of Durvadi tail matra basti in Parikartika with special reference to 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 |
Dr Suresh Malakari Dhayagonde |
| Designation |
PG Scholar Shalyatantra Department |
| Affiliation |
Yashwant Ayurveda college kodoli Kolhapur |
| Address |
Yashwant Ayurvedic College,PG training and research centre Kodoli Kolhapur
Kolhapur
MAHARASHTRA
416614
India |
| Phone |
9822636852 |
| Fax |
|
| Email |
sureshdhayagonde1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sayaji Desai |
| Designation |
Professor Shalyatantra Department. |
| Affiliation |
Yashwant Ayurveda college Kodoli Kolhapur. |
| Address |
Shalyatantra Department Yashwant Ayurvedic College PG training and research centre Kodoli Kolhapur
Kolhapur
MAHARASHTRA
416614
India |
| Phone |
9423282354 |
| Fax |
|
| Email |
drsayaji@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayaji Desai |
| Designation |
Professor Shalyatantra Department. |
| Affiliation |
Yashwant Ayurveda college Kodoli Kolhapur. |
| Address |
Shalyatantra Department Yashwant Ayurvedic College PG training and research centre Kodoli Kolhapur
Kolhapur
MAHARASHTRA
416614
India |
| Phone |
9423282354 |
| Fax |
|
| Email |
drsayaji@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Kodoli Kolhapur |
|
|
Primary Sponsor
|
| Name |
Yashwant Ayurvedic College Kodoli Kolhapur |
| Address |
Yashwant Ayurvedic College,PG Training And Research Centre, Kodoli, Tal-Panhala,Dis-Kolhapur |
| 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 Suresh Dhayagonde |
Yashwant Ayurvedic College |
Shalyatantra OPD
Yashwant Ayurvedic College PG training and research center Kodoli Tal Panhala Dis Kolhapur
Kolhapur
MAHARASHTRA |
09822636852
sureshdhayagonde1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Durva tail , Reference: Bha.Bh.Ratnavali yog no 3108, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Triphala Guggulu Vati 500mg 2 BD with Warm water.
Gandharv Haritaki Vati 500mg 2 HS.(2) Medicine Name: Gandharv Haritaki Vati , Reference: Well known Drug, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: No | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala Guggulu, Reference: Well known Drug, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: No | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatdhout Ghrita, Reference: Well known Drug, Route: Topical, Dosage Form: Ghrita, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: No(2) Medicine Name: Gandharv Haritaki Vati, Reference: Well known Drug, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: No(3) Medicine Name: Triphala Guggulu Vati, Reference: Well known Drug, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: No |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Anal fissure within 1month.
Physical examination revealed fissure in ano.
Patient complaining of severe burning sensation in anus after defecation. |
|
| ExclusionCriteria |
| Details |
Any chronic illness like known c/o TB,HIV/AIDS patient.
Pregnant Womens.
Patient suffering from Haemorrhoids,Anal fistula,Peri anal abscess,Known case of Carcinoma of rectum etc. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the role of Durvadi tailam matra basti in the management of Parikartika with special reference to Fissure in ano. |
0th 7th 14th 21th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study Parikartika vyadhi from Ayurvedic literature.
To study Fissure in ano from modern literature.
To study the etiopathogenesis of Fissure in ano according to Ayurveda and modern books. |
7th 14th 21th Day |
|
|
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)
|
10/10/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Clinical Research Project named as Randomized Open Controlled Clinical study on the role of Durvadi tail matra basti in Parikartika with Special reference to fissure in ano. As it is a very common and painful condition hampering life of patient.Above research is made to cure the disease from the root. |