| CTRI Number |
CTRI/2024/07/070952 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate effect of kharjuradi mantha along with yoga meditation and counselling in alcohol withdrawal symptoms |
|
Scientific Title of Study
|
Effect of kharjuradi mantha as an add on in the management of alcohol withdrawal symptoms along with yoga meditation and counselling - a randomised controlled trail |
| 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 Nandini A |
| Designation |
PG Scholar |
| Affiliation |
Amrita school of Ayurveda |
| Address |
Department of ayurveda Samhita and Siddhanta,
Amrita School of Ayurveda,
Amrita Vishwa Vidyapeetham,
Amritapuri, Clappana.
Kerala, India – 690 525.
Kollam
KERALA
690525
India |
| Phone |
9481915329 |
| Fax |
|
| Email |
nanduad.2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leena P Nair |
| Designation |
Professor and Head of the Department |
| Affiliation |
Amrita school of Ayurveda |
| Address |
Department of Ayurveda Samhita Siddhanta,
Amrita School of Ayurveda,
Amrita Vishwa Vidyapeetha,
Amritapuri, Clappana.
Kerala, India – 690 525.
Kollam
KERALA
690525
India |
| Phone |
7907673112 |
| Fax |
|
| Email |
rkslpn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Leena P Nair |
| Designation |
Professor and Head of the Department |
| Affiliation |
Amrita school of Ayurveda |
| Address |
Department of Ayurveda Samhita Siddhanta,
Amrita School of Ayurveda,
Amrita Vishwa Vidyapeetham,
Amritapuri, Clappana.
Kerala, India – 690 525.
Kollam
KERALA
690525
India |
| Phone |
7907673112 |
| Fax |
|
| Email |
rkslpn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tapovana de-addiction centre,1st floor
hospital block, Tapovana Ayurvedic medical college and Hospital,
Harihara road, Doddabathi, Davangere, KARNATAK, 577566 |
|
|
Primary Sponsor
|
| Name |
Dr Nandini A |
| Address |
Department of Ayurveda Samhita siddhanta
Amrita School of Ayurveda,
Amrita Vishwa Vidyapeetham,
Amritapuri, Clappana.
Kerala, India – 690525. |
| 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 |
| Dr Nandini A |
Tapovana Ayurvedic Medical college and Hospital. |
Tapovana De-addiction Center,Room No 1,2 and 3, 1st floor, Hospital block, Tapovana Ayurvedic Medical college, Doddabathi.Davangere - Harihar Road, Karnataka 577566
Davanagere
KARNATAKA |
9481915329
nanduad.2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tapovana ayurvedic medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F102||Alcohol dependence. Ayurveda Condition: MADATYAYAH/PANATYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kharjuradi Mantha , Reference: 7th chapter, Phanta Yoga Prakaranam,Sahasrayogam., Route: Oral, Dosage Form: Mantha, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Shrutasheeta jala ), Additional Information: - | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:yoga & meditation- one hour per day for 28days And Counselling -weekly once for 1 hour for 4 weeks by Psychologists[expert], Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1.Participants who are willing to sign the informed consent form.
2.Male Participants undergoing treatment for alcohol withdrawal symptoms.
3.Participants who are all fulfilling minimum 3-4 symptoms of DSM-5.
4.Participants who scores more than 15 in AUDIT scale assessment.
5.Age group of 25-60years were selected.
• Not under any internal treatment for alcohol withdrawal symptoms. |
|
| ExclusionCriteria |
| Details |
1.Patients diagnosed with high-risk diseases.
2.Cardiac disorders like IHD, cardiogenic shock, infective Endocarditis and any systemic disorders like Diabetics are excluded.
3.Severe stage of liver cirrhosis, acute hepatitis, liver abscess etc. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in score of CIWA-AR-Clinical institute withdrawal assessment of alcohol scale, revised. |
28DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
29/08/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study randomised parllel group, designed to evaluate the effect of Kharjuradi mantha as an add on in the management of alcohol withdrawal symptoms along with yoga meditation & counselling in the patients aged between 25-60yrs, over the period of 28days.The outcome will be measured based on score of CIWA-AR-Clinical institute withdrawal assessment of alcohol scale, revised. |