| CTRI Number |
CTRI/2022/05/042856 [Registered on: 27/05/2022] Trial Registered Prospectively |
| Last Modified On: |
26/05/2022 |
| 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
|
To study the effect of Haritaki mixed with Gavya-ghrita in vivandha patient. |
|
Scientific Title of Study
|
A Conceptual study on Samyoga Guna with special reference to effect of Haritaki mixed with Gavya-Ghrita |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monalisa Hansdah |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic College and Hospital Balangir |
| Address |
PG Department of Ayurveda Samhita and Siddhant
Government Ayurvedic College and Hospital Balangir
Balangir
ORISSA
767001
India |
| Phone |
8763448404 |
| Fax |
|
| Email |
hansdah07monu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Dr Manoj Kumar Sahoo |
| Designation |
Professor and Head |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
PG Department of Ayurveda Samhita and Siddhant
Government Ayurvedic College and Hospital Balangir
Balangir
ORISSA
767001
India |
| Phone |
8917359659 |
| Fax |
|
| Email |
drkumarmanoj66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Professor Dr Manoj Kumar Sahoo |
| Designation |
Professor and Head |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
PG Department of Ayurveda Samhita and Siddhant
Government Ayurvedic College and Hospital Balangir
Balangir
ORISSA
767001
India |
| Phone |
8917359659 |
| Fax |
|
| Email |
drkumarmanoj66@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt.Ayurvedic college and Hospital,Balangir Odisha
|
|
|
Primary Sponsor
|
| Name |
Monalisa Hansdah |
| Address |
PG Department of Ayurveda Samhita and Siddhant
Government Ayurvedic College and Hospital, Balangir |
| 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 |
| Professor Dr Manoj Kumar Sahoo |
Government Ayurvedic College and Hospital Balangir |
OPD of RogaNidana Room no-2
Balangir
ORISSA |
8917359659
drkumarmanoj66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurvedic College and Hospital Balangir |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ghritaharitaki yoga, Reference: Charak Samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -ghrita ), Additional Information: Taking laghu ahara, ushna,snigdha bhojan | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritaki churna , Reference: Charak Samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: Taking laghu,ushna snigdha bhojana |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of sex in the age between 18-60yr.
2.Straning during bowels.
3.Krura kostha(Passing of hard,lumphy stools)
4.Sensation of incomplete evacuation. |
|
| ExclusionCriteria |
| Details |
constipation associated with other systemic illness and diseases like external and internal piles,fissures,CA anus and fistula-in-ano,hypothyroidism.Patients of both sex in the age below 18 and above 60yrs.
Ajirna,madyapidita,Visha pidita,trisna,Ardita and Garbhini. |
|
|
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 decrease the sign and symptoms of Vibandha like Sirashoola,Adhmana,Pakwasayashhola and Vatavarchhapravruti |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the effectiveness of Ghrita haritaki yoga and Haritaki churna |
15 days |
|
|
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 |
|
Date of First Enrollment (India)
|
30/05/2022 |
| 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
|
The study will be submitted in the form of Dissertation to Sambalpur University as a part of Post Graduate Course |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Conceptual study on Samyoga Guna with special reference to effect of Haritaki mixed with Gavya-ghrita.This is done compulsory part of Post Graduate Course. Total No. of Patients to be studied is 60 with duration of 30 days.Purpose of trial is to see effect of the samyoga guna between Gavyaghrita and haritaki in Vibandha in comparison wth haritaki churna only |