| CTRI Number |
CTRI/2024/05/067315 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the Effectivness of Saptang gugglu and madhuyasti ghrit in the management of Parikartika |
|
Scientific Title of Study
|
A clinical study Saptang Gugglu and Madhuyashti Ghrit in the Management of Parikartika w.s.r to Fissure-in-Ano |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepali Sundari Verma |
| Designation |
Head and Professor |
| Affiliation |
Government Ayurvedic College Patna Bihar |
| Address |
Department of shalya tantra
Government Ayurvedic College
kadamkuan Patna Bihar
Patna
BIHAR
800003
India
Patna
BIHAR
800003
India |
| Phone |
9430471341 |
| Fax |
|
| Email |
drdeepali261996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Sundari Verma |
| Designation |
Head and Professor |
| Affiliation |
Government Ayurvedic College Patna Bihar |
| Address |
Department of shalya tantra
Government Ayurvedic College
kadamkuan Patna Bihar
Patna
BIHAR
800003
India
BIHAR
800003
India |
| Phone |
9430471341 |
| Fax |
|
| Email |
drdeepali261996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepali Sundari Verma |
| Designation |
Head and Professor |
| Affiliation |
Government Ayurvedic College Patna Bihar |
| Address |
Department of shalya tantra
Government Ayurvedic College
kadamkuan Patna Bihar
Patna
BIHAR
800003
India
BIHAR
800003
India |
| Phone |
9430471341 |
| Fax |
|
| Email |
drdeepali261996@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD 14 Government Ayurvedic College and hospital, Kadamkuan Patna Bihar- 800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital Patna Bihar |
| Address |
Department of shalya tantra Government Ayurvedic College and Hospital Kadamkuan Patna Bihar |
| Type of Sponsor |
Research institution 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 |
| Dr Sameeksha Pal |
Government Ayurvedic College and Hospital, Kadamkuan, Patna |
3rd floor
Department of Shalya Tantra,Government Ayurvedic College and hospital,patna
Patna
BIHAR |
7974405695
sameeksha.pal1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE , PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saptang gugglu, Reference: Bhaiyashajya ratnawali , vransodha adhikar -47, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Madhuyasti ghrita, Reference: Bhaishajya ratnawali vidyotani bhasha tika samhita sadhyovrana chikitsa chapter 48, Route: Rectal, Dosage Form: Ghrita, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: 60 Days, Reference: No, Route: NA, Dosage Form: Ghrita, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Total 30 patients of fissure in ano will be selected randomly from OPD Department of Shalya tantra of government Ayurvedic College
& Hospital, Patna
2. Duration of trial-60 days.
3. Follow up-After every 15 days
4. Patient age group 20-60years of age.
5. Patients classically diagnosed with Fissure –in-An |
|
| ExclusionCriteria |
| Details |
HIV &HbsAg patients
Diabetic patient
Chronic fissure
Chronic fissure with tag
Fissure d/t any other systemic disorder-
Ulcerative colitis
Crohns disease
Tuberculosis
Carcinoma of Rectum & Anal canal
Chronic patient with 4th grade anal spasm will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical sign and symptoms(pain , itching per anal) of parikartika |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
02/06/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
People are getting more affected by Ano -Rectal diseases. The global burden of diseases project
has shown that it hamper quality life of patient. Among all ano rectal diseases fissure in ano among
all age group more prevalence in younger.Present trial is planned for management of fissure in ano
with drug saptang guggulu and madhuyashti ghrit mentioned in ayurved text. total 60 patients will
be registered randomly from OPD GACH Patna. Duration of trial is 60 days |