| CTRI Number |
CTRI/2020/12/029509 [Registered on: 02/12/2020] Trial Registered Prospectively |
| Last Modified On: |
24/11/2020 |
| 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 Sarjaras
Malahara In The Management Of Parikartika.
|
|
Scientific Title of Study
|
Randomised Controlled Clinical Study To Evaluate The Efficacy Of Sarjaras
Malahara With Shatadhaut Ghrita In The Management Of Parikartika.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kiran Panditrao Jagade |
| Designation |
PG student Surgery Department |
| Affiliation |
Sumatibhai Shah ayurved mahavidyalya hadapasar pune |
| Address |
OPD No3 Sane Guruji Hospital Malwadi Hadapsar Pune
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8830974907 |
| Fax |
|
| Email |
kiranjagade248@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Narkhede |
| Designation |
Lecturer Surgery Department |
| Affiliation |
Sumatibhai shah ayurved mahavidyalya malwadi hadapasar pune |
| Address |
OPD No3 Sane Guruji Hospital Malwadi Hadapsar Pune
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9850200998 |
| Fax |
|
| Email |
dryogeshnarkhede10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kiran Panditrao Jagade |
| Designation |
PG student Surgery Department |
| Affiliation |
Sumatibhai Shah ayurved mahavidyalya hadapasar pune |
| Address |
OPD No3 Sane Guruji Hospital Malwadi Hadapsar Pune
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8830974907 |
| Fax |
|
| Email |
kiranjagade248@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sane Guruji HospitalHadapsar Pune |
|
|
Primary Sponsor
|
| Name |
Kiran Panditrao Jagade |
| Address |
OPD No3 Sane Guruji Hospital Malwadi Hadapsar Pune |
| 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 |
| Kiran Panditrao Jagade |
Sane Guruji hospital |
OPD No3 Shalyatantra Department Sane Guruji Hospital Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
8830974907
kiranjagade248@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe , SSAM hadapasar pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Randomised Controlled Clinical Study To Evaluate The Efficacy Of Sarjaras
Malahara With Shatadhaut Ghrita In The Management Of Parikartika. |
Nowadays because of altered lifestyle about 30 to 40% of the population
suffer from proctology pathology; in that fissure-in-ano has become most common
and painful condition which hampers the daily activity of the person. Keeping the above factors, in Ayurveda there are so many preparations
mentioned. Sarajaras Malahara[9}
is one of such a kind. Hence here an attempt is
made to manage Parikartika with Sarajaras Malahara. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Per rectal bleeding
Pain while defecation
Hard stool
Anal Spasm
Both gender between the age group of 18-45yr.
Patients having Parikartika and its symptoms. |
|
| ExclusionCriteria |
| Details |
Parikartika secondary to ulcerative colitis, Chrohn’s disease, Syphilis, and
Tuberculosis
Bleeding disorders
Sickle cell anemia
K/C/O- HIV and HBsAg
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the Sarajras Malahara is effective in the management of Parikartika |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
There is no difference in efficacy of Sarajras Malahara and Shatadhaut Ghrita in
the Parikartika.
There is Sarajras Malahara is less effective than Shatadhaut Ghrita in the
management of Parikartika.
|
1 yr |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/12/2020 |
| 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="0"
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
|
Title- Randomised Controlled Clinical Study To Evaluate The Efficacy Of Sarjaras Malahara With Shatadhaut Ghrita In The Management Of Parikartika. Sample size - 60 Inclusion Criteria- Per rectal bleeding Pain while defecation Hard stool Anal Spasm Both gender between the age group of 18-45yr Patients having Parikartika and its symptoms Exclusion Criteria- Parikartika secondary to ulcerative colitis Chrohn’s disease, Syphilis, and Tuberculosis Bleeding disorders Sickle cell anemia K/C/O- HIV and HBsAg |