| CTRI Number |
CTRI/2025/09/094469 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Ayurveda treatment protocol] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to check the effect of Ayurveda treatment protocol in madatyaya (Alcohol Use Disorder). |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Ayurveda treatment protocol in madatyaya w.s.r. to alcohol use disorder – A black box study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khandizod Sandesh Suresh |
| Designation |
PG Scholar |
| Affiliation |
PG Department of Agad Tantra, IAS&R, Shri Krishna AYUSH University, Kurukshetra |
| Address |
PG department of Agadtantra, IAS&R, Shri Krishna AYUSH University, Umri road, Sector 8, Kurukshetra.
Kurukshetra
HARYANA
136118
India |
| Phone |
9021627835 |
| Fax |
|
| Email |
drsandeshkhandizod@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Khandizod Sandesh Suresh |
| Designation |
PG Scholar |
| Affiliation |
PG Department of Agad Tantra, IAS&R, Shri Krishna AYUSH University, Kurukshetra |
| Address |
PG department of Agadtantra, IAS&R, Shri Krishna AYUSH University, Umri road, Sector 8, Kurukshetra.
HARYANA
136118
India |
| Phone |
9021627835 |
| Fax |
|
| Email |
drsandeshkhandizod@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Khandizod Sandesh Suresh |
| Designation |
PG Scholar |
| Affiliation |
PG Department of Agad Tantra, IAS&R, Shri Krishna AYUSH University, Kurukshetra |
| Address |
PG department of Agadtantra, IAS&R, Shri Krishna AYUSH University, Umri road, Sector 8, Kurukshetra.
HARYANA
136118
India |
| Phone |
9021627835 |
| Fax |
|
| Email |
drsandeshkhandizod@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurveda Studies and Research, Faculty of Ayurveda, Shri Krishna AYUSH University, Kurukshetra |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurveda Studies and Research, Shri Krishna AYUSH University, Kurukshetra |
| Address |
Institute for Ayurveda Studies and Research, Shri Krishna AYUSH University,Umri road, Sector 8,Kurukshetra, 136118 |
| Type of Sponsor |
Other [Government Ayurveda College ] |
|
|
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 Satbir Kumar Chawla |
Institute for Ayurveda Studies and Research, Shri Krishna AYUSH University, Kurukshetra |
Room no. 85, PG department of Agad Tantra, Institute for Ayurveda Studies and Research, Faculty of Ayurved, Shri Krishna AYUSH University, Umri road, Sector 8, Kurukshetra, 136118.
Kurukshetra
HARYANA |
9813348824
satbirchawla4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shri Krishna AYUSH Universiity |
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 | Procedure | - | Shirodhara | (Procedure Reference: , Procedure details: Shirodhara with Til taila will be given for 30 minutes for 15 days)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kharjuradi Mantha, Reference: Charak Sutrasthana 23/38, Route: Oral, Dosage Form: Mantha, Dose: 48(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Ashwagandharistha, Reference: Bhaishajya ratnavali 21/15-21, Route: Oral, Dosage Form: Arishta, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -(3) Medicine Name: Bramha Rasayan, Reference: Asthang Haridya Uttarardha 39/15-23, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: hs, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
1. Patients who have a mild to moderate range (Score 0-15) of CIWA-Ar Scale
2. Patients of either sex in the age range of 18–60 years, irrespective of caste, religion, economic status,
and marital status.
3. Patients who are not receiving any contemporary de-addiction treatment. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1. Patient with a severe range (more than15) of symptoms CIWA-Ar Scale
2. Patients with potentially co-morbid diseases like Coronary Artery Disease (CAD), malignancy, renal failure, Liver Disease (III, IV- Stage), Heart failure etc.
3. Patients with significant psychiatric co-morbidity (e.g. schizophrenia, major depressive disorder, or severe anxiety Disorder).
4. Pregnant and lactating mothers.
5. Patients with a history of multiple drug addictions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Score of the CIWA-Ar Scale and Insomnia Severity Index. |
30 days+ 15 days follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes in the Signs and Symptoms of Madatyaya.
2.Change in levels of CBC, and LFT.
3.Changes in the score of the quality of life assessment scale, WHO-QOL-bref. |
30 days and follow up after 15 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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)
|
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
|
Madatyaya is described very well in Ayurvedic texts. It can be compared with Alcohol Use Disorder(AUD) in accordance with the modern science. Hence, An Ayurveda treatment protocol will be tested in this study to check its efficacy in the management of patients diagnosed with AUD considering inclusion criteria. Worldwide accepted standard scales like AUDIT, CIWA Ar, ISI, WHO QOL BREF will be used in this study for diagnosis, inclusion and assessment. The present Ayurveda treatment protocol includes Kharjuraji mantha, Ashwagandha arishta, Bramha rasayan, Til tail shirobasti, yoga and Satvavajaya Chikitsa. 30 patients will be studied in a single group for 30 days along with follow up after 15 days. Observations will be gathered and statistically tested to get final results, upon which proposed research question will be tested. |