| CTRI Number |
CTRI/2020/03/023909 [Registered on: 12/03/2020] Trial Registered Prospectively |
| Last Modified On: |
21/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare effect of Darvighrita and Yashtimadhughrita for local application in parikartika (fissure in ano) |
|
Scientific Title of Study
|
A Randomised controlled clinical trial to evaluate efficacy the Darvighrita and Yashtimadhughrita for local application in parikartika (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 |
Atul Baburao Tambade |
| Designation |
P.G.Scholar |
| Affiliation |
PDEAS College of ayurved and research centre |
| Address |
Ayurved rugnalay and sterling multispeciality hospital, Department Of shalyatantra, OPD No.123.Sector no 27,pradhikaran, Nigdi Pune.
PDEAS College of ayurved and research centre,Sector No.25,
Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044.
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8600378637 |
| Fax |
|
| Email |
atatultambade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhalchandra N Deshpande |
| Designation |
Professor Shalyatantra department |
| Affiliation |
PDEAS College of ayurved and research centre |
| Address |
Ayurved rugnalay and sterling multispeciality hospital, Department Of shalyatantra, OPD No.123.Sector no 27,pradhikaran, Nigdi Pune.
PDEAS College of ayurved and research centre,Sector No.25,
Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044.
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9970108596 |
| Fax |
|
| Email |
drbndeshpande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Atul Baburao Tambade |
| Designation |
P.G.Scholar |
| Affiliation |
PDEAS College of ayurved and research centre |
| Address |
Ayurved rugnalay and sterling multispeciality hospital, Department Of shalyatantra, OPD No.123.Sector no 27,pradhikaran, Nigdi Pune.
PDEAS College of ayurved and research centre,Sector No.25,
Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044.
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8600378637 |
| Fax |
|
| Email |
atatultambade@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurved and research centre Sector no 25, Pradhikaran,Nigdi,Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurved and research centre |
| Address |
sector no 25, Padhikaran , Nigdi,pune 411044 |
| 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 |
| Atul Baburao Tambade |
Ayurved rugnalay and sterling multispeciality hospital,Nigdi |
Department Of
Shalyatantra, OPD No.123. Sector no 27,pradhikaran, Nigdi Pune
Pune
MAHARASHTRA |
8600378637
atatultambade@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K600||Acute anal fissure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Darvighrita |
Group-A: Minimum of 34 patients Procedure: Per rectal application of DarviGhrita Pichu 2 times daily Duration- 14 days
follow up on 5th,7th,10th,14th days |
| Comparator Agent |
yashtimadhughrita |
Group-B: Minimum of 34 patient Procedure: Per rectal application of YashtimadhuGhrita Pichu 2 times daily Duration- 14 days
follow up on 5th,7th,10th,14th days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A.Patients diagnosed as having Parikartika(Fissure-in-Ano)
B. Patients of both sexes in between the age group of 18 and 60years
C.Patients of Parikartika with systemic diseases like Diabetes and Hypertension which are well under control were also included in the study.D.Female patients with pregnancy will be also included
|
|
| ExclusionCriteria |
| Details |
Patients having Parikartika (Fissure-in-Ano) secondary to Ulcerative colitis, Chron’s disease, Syphilis, Tuberculosis and Ca. of rectum of anal canal.
Chronic fissure
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of DARVI GHRITA and YASHTIMADHU GHRITA in Parikartika within 14 days |
5th,7th,10th,14th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe adverse drug reaction, if any. |
5th,7th,10th,14th day |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
20/03/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/03/2020 |
| 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 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)?
|
Brief Summary
Modification(s)
|
Parikartika is one of the commonest anorectal diseases. This disease is not life threatening but very painful for the sufferers in this modern era where the medical science is on peak requires surgical intervention for Fissure-in-Ano. These conventional surgical procedures such as Lord’s dilatation, Fissurectomy, Sphincterotomy14 etc. The result of all these procedures causes many complications18,24. To bring back, the past glory of Ayurvedi chikitsa, in the field of proctology has lot of scope for research25. Hence, this condition has been attracting Ayurvedic surgeons and physicians for ideal and suitable curative medication .Sushruta had mentioned 4 fold therapeutic procedures such as Oushadi, Kshara, Agni and Shastra karma4. Thus, in the present study the drug “DarviGhrita†selected as Oushadi and applied in the form of Picchu. Thus, in this study, the attempt is being made to observe the effect of “DarviGhrita†in treatment of Parikartika. So far, there have been many researches carried out in different institutions regarding Parikartika19,21,22. Moreover, there has been no work carried out on local management of Parikartika with “DarviGhritaâ€. Hence, an attempt is being made to see the effect of “DarviGhrita†instead of any surgical intervention |