| CTRI Number |
CTRI/2023/07/055173 [Registered on: 13/07/2023] Trial Registered Prospectively |
| Last Modified On: |
12/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to access the efficacy of go mutra haritaki over guda haritaki in the management of haemorrhoids |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF GOMUTRA HARITAKI OVER GUDA HARITAKI IN MANAGEMENT OF SHUSKARSHA WITH SPECIAL REFERENCE TO 2nd DEGREE INTERNAL HAEMORRHOIDS†|
| 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 Altaf Ustad |
| Designation |
BAMS PG SCHOLAR |
| Affiliation |
BLDEAS AVS AMV HOSPITAL AND RESEARCH CENTRE |
| Address |
Department of Shalyatantra ,BLDEAS AVS Ayurveda Mahavidyalaya ,Hospital and research centre Vijayapura -586109 INDIA
Bijapur
KARNATAKA
586109
India |
| Phone |
7026958074 |
| Fax |
|
| Email |
altafustad429@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aneesur Rehman M Madni |
| Designation |
Associate Professor |
| Affiliation |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYPURA |
| Address |
Dept. of PG Studies in Shalyatantra, BLDEAS AVS Ayurveda Mahavidyalaya ,Hospital and research centre Vijayapura -586109 INDIA
Bijapur
KARNATAKA
586109
India |
| Phone |
9538140448 |
| Fax |
|
| Email |
anees8804@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aneesur Rehman M Madni |
| Designation |
Associate Professor |
| Affiliation |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYPURA |
| Address |
Dept. of PG Studies in Shalyatantra, BLDEAS AVS Ayurveda Mahavidyalaya ,Hospital and research centre Vijayapura -586109 INDIA
Bangalore Rural
KARNATAKA
586109
India |
| Phone |
9538140448 |
| Fax |
|
| Email |
anees8804@gmail.com |
|
|
Source of Monetary or Material Support
|
| shalyatantra OPD, BLDEAs AVS Ayurveda Mahavidyalaya Vijayapur |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
nil |
| Type of Sponsor |
Other [pg thesis] |
|
|
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 Altaf H Ustad |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYPURA |
Dept. Shalyatantra ,BLDEAS AVS Ayurveda Mahavidyala Vijayapur
Bijapur
KARNATAKA |
7026958074
altafustad429@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gomutra haritaki, Reference: charaka samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: sukoshna jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: guda haritaki, Reference: charaka samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: Yes, Route: sukoshna jala, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient fullfilling the diagnostic criteria
2.patient with age between 16 to 70 years
3.Patient of either sex irrespective of Religion ,Occupation & Economic status
|
|
| ExclusionCriteria |
| Details |
1)patient suffering from internal haemorrhoids along with fistula in ano, fissure in ano, anorectal abscess and rectal prolapse
2)pregnant women and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of pile mass |
28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of pain and burning sensation duing defication |
28 days |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 3 |
|
Date of First Enrollment (India)
|
27/07/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
this study is randomized comparative clinical study to evaluate the efficacy of gomutra haritaki over guda haritaki in the management of suskarsha with special reference to 2nd degree haemorrohida will be conducted in BlDEAS AVS Ayurveda mahavidyalaya hospital and research centre, Vijayapur 586109 Karnataka |