| CTRI Number |
CTRI/2025/07/091269 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efeect of Satvavajaya chikitsa,Jaladhara and Shreekhandasava in Madatyaya |
|
Scientific Title of Study
|
“An open label clinical study to evaluate the effect of Satvavajaya chikitsa, Jaladhara and Shreekhandasava in the management of madatyaya wsr alcohol withdrawal syndromee
|
| 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 Shilpa |
| Designation |
Pg scholar |
| Affiliation |
|
| Address |
Opd-3 Department of Manovijnyana evum Manasaroga
Sdm college of Ayurveda and hospital Kuthpady Udupi Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9035606858 |
| Fax |
|
| Email |
shilpasp595@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrilatha kamath T |
| Designation |
Professor and Hod HOD Dept of Kayachikitsa and Manasaroga |
| Affiliation |
|
| Address |
Sdm College of Ayurveda and Hospital Kuthpady UDupi Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9964899638 |
| Fax |
|
| Email |
shri9503@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrilatha kamath T |
| Designation |
Professor and Hod Dept of Kayachikitsa and Manasaroga |
| Affiliation |
|
| Address |
Sdm College of Ayurveda and Hospital Kuthpady Udupi Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9964899638 |
| Fax |
|
| Email |
shri9503@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Ayurveda Pharmacy Laxminarayana Nagar Kuthpady Udupi Karnataka India 574118 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Shilpa |
Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady |
opd-3 Manasaroga
Shri Dharmasthala manjunatheshwara college of Ayurveda and Hospital KUTHPADY Udupi
Udupi
KARNATAKA |
09035606858
shilpasp595@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commete |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F101||Alcohol abuse, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Satvavajaya chikitsa
Jaladhaara
Shreekhandasavaa
|
Satvavajaya -30min sessions will be
held daily in between
4pm to 5pm
.
Jaladhaara -Dhara with 1½ liter of jala every day in the
morning in between 8:00 to 11 am for 30 minutes.
Shreekhandasavaa -24 ml twice in a day after food
with the anupana of equal quantity of shruta
sheeta jala
, every day for 14 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed cases of Madatyaya wsr Alcohol Withdrawal Syndrome as per the diagnostic criteria
2. Ages eligible for study 18 to 70 years of age irrespective of socioeconomic status
3. Both male and female are eligible for the study
4. Participants or relatives willing to give informed consent and comply with study procedures
|
|
| ExclusionCriteria |
| Details |
1.Ascites clinical gate more than 3
2.Pregnant women and lactating mothers
3. Systemic diseases which interfere with disease process and present clinical trial
4.Patient suffering from the other type of addiction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parameters will be scored by standard method and will be assessed before and after treatment on Seth 14th day
1diagnosed cases of Madatyaya wsr alcohol withdrawal syndrome as per the diagnostic criteria CIWA-Ar scale
2 Manasika bhava scale
statistical analysis
All scored parameters will be analyzed statistically after the treatment on 14th days all the subjective parameters and scales will be assessed using Wilcoxon signed rank test |
Parameters will be scored by standard method and will be assessed before and after treatment on 0th 14th day
( at 2 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 2 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Conceptual understanding of Madya (Alcohol) as a Nidana for
Mananovikara (Psychological Disorders) w.s.r. to Alcohol Use Disorders. JAIMS journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an open label clinical study to evaluate the combined effect of Satvavajaya, jaladhaara and Shreekhandasavaa in Madatyaya . Satvavajaya -30min sessions will be held daily in between 4pm to 5pm. Jaladhaara - Dhara with 1½ liter of jala15 every day in the morning in between 8:00 to 11 am for 30 minutes.
shreekhandasava- 24l twice in a day after food with the anupana of equal quantity of shrutaSheeta jala every day for a period of 14 days .The study will be conducted in Shri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi. The primary measures will be assessed form baseline in objective criteria CIWA-Ar scale and Manasika bhava scale.Hence, the study is an effort to prove the combined effect of Satvavajaya, jaladhaara and Shreekhandasavaa in Madatyaya w.s.r to alcohol withdrawal syndrome. |