CTRI/2024/11/076314 [Registered on: 06/11/2024] Trial Registered Prospectively
Last Modified On:
05/11/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Other
Public Title of Study
Effect of combined treatment protocol including Ayurveda, Yoga and Psychotherapy in drug addiction
Scientific Title of Study
Effectiveness of an Integrated Protocol in Substance Use Disorder- A Black Box Design
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Reshmi Krishnan
Designation
MD Scholar
Affiliation
VPSV Ayurveda college Kottakal
Address
Department of Manovigyan evam Manasaroga
VPSV Ayurveda College Kottakkal
Malappuram
Malappuram KERALA 676501 India
Phone
9539169293
Fax
Email
resmimidu@gmail.com
Details of Contact Person Scientific Query
Name
Dr Jithesh M
Designation
Professor and Head of the Department
Affiliation
VPSV Ayurveda college Kottakal
Address
Department of Kayachikitsa
VPSV Ayurveda College Kottakkal Malappuram
Malappuram KERALA 676501 India
Phone
9447882885
Fax
Email
drjitheshm@gmail.com
Details of Contact Person Public Query
Name
Dr Jithesh M
Designation
Professor and Head of the Department
Affiliation
VPSV Ayurveda college Kottakal
Address
Department of Kayachikitsa
VPSV Ayurveda College Kottakkal
Malappuram
Malappuram KERALA 676501 India
Phone
9447882885
Fax
Email
drjitheshm@gmail.com
Source of Monetary or Material Support
nil
Primary Sponsor
Name
Reshmi Krishanan
Address
VPSV Ayurveda Medical College Kottakkal Malappuram
Kerala
676501
Type of Sponsor
Other [Self]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 2
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr APARNA P M
Government Ayurveda Research Institute for Mental Health and Hygiene , KOTTAKKAL
Room number-2 , Ground floor Government Ayurveda and Research Institute for Mental Health and Hygeine , Kottakkal Malappuram KERALA
8547153042
aparnapullurmadathil@gamil.com
Dr JITHESH M
VPSV Ayurveda College Hospital Kottakkal
Room number -205, First floor
Manashanthi OPD
VPSV Ayurveda College Hospital,Kottakkal , Malappuram Malappuram KERALA
9447882885
drjitheshm@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee (IEC)[ Institutional Review Board(IRB)] and NOC from Government Ayurveda Research Institute for Mental Health and Hygiene
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:F10-F19||Mental and behavioral disorders due to psychoactive substance use. Ayurveda Condition: MADATYAYAH/PANATYAYAH,
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Intervention Arm
Procedure
-
aBya~ggaH, अà¤à¥à¤¯à¤‚ग AND UShmasvedaH ऊleेदः
(Procedure Reference: Keraleeya panchakarmavidhi, Procedure details: 30m minutes of abyanga followed by 20 minutes of sweda on 18th & 19th day of intervention) (1) Medicine Name: Dhanwantara tailam , Reference: Sahasra yogam 25/33-38, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 2 Days
2
Intervention Arm
Procedure
-
virecana-karma िवरेचन-कम
(Procedure Reference: Ashtanga hridaya sootrasthana 18/33-45 , Procedure details: 25gm of Avipathi churna will be given along with Luke warm water in between 6am to 7am for the first day as sadyovirechana for koshtashudhi) (1) Medicine Name: Avipattichurnam, Reference: Sahasrayogam - churnaprakarana 47-48, Route: Oral, Dosage Form: Churna/ Powder, Dose: 25(g), Frequency: od, Duration: 1 Days
3
Intervention Arm
Procedure
-
SiraHsekaH, शिरःसेकः
(Procedure Reference: Dharakalpam 5/33-36, Procedure details: SiraHsekaH will be done with 3 liter of Usira kwatha at 9 am for 30 minutes from second day to eighth day of intervention) (1) Medicine Name: Usira kwatha, Reference: Kwathakalpana vidhi of Saranghadhara samhitha, Madyama khanta 5/1-15 , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 3(NA), Frequency: od, Duration: 7 Days
4
Intervention Arm
Drug
Classical
(1) Medicine Name: Sarpagandha churna, Swetha shankapushpi churna and Gokshura churna, Reference: Ayurveda pharmacopeia of India volume 1 page number 134-137; volume 3 page number 24-27 and volume 2 page number 133-136 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -Sarpagandha churna, Swetha shankapushpi churna and Gokshura churna will be taken in 1:1:1 ratio and will be given from second day to eighth day
5
Intervention Arm
Procedure
-
talam, तलमà¥
(Procedure Reference: Keraleeya Panchakarmavidhi 7/15-20, Procedure details: Talam with Kachuradhi churna & Ksheerabala tailam (3ml) will be done in between 5pm to 6 pm for half an hour from second day to eighth day ) (1) Medicine Name: Kachuradi churna, Reference: Sahasrayogam churnaprakarana 10/33-35, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 5(g), Frequency: od, Duration: 7 Days
6
Intervention Arm
Drug
Classical
(1) Medicine Name: Kharjuradhi Mantha, Reference: Sahasrayogam 12/33-34, Route: Oral, Dosage Form: Mantha, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Kharjuradhi mantha will be given from second day to eighth day
7
Intervention Arm
Drug
Classical
(1) Medicine Name: Somalatha churna, Reference: Ayurveda pharmacopeia of India volume 4 page number 12-15, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -
8
Intervention Arm
Drug
Classical
(1) Medicine Name: Kalyanaka gritham/ Datryadi grithm/ Mahat panchagavya grithm, Reference: Sahasrayogam 17/47-50 / Ashtanga hridaya Chikitsasthana 6/47-58 /Ashtanga hridaya uttarasthana 39/53-55, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Warm water), Additional Information: -Gritha will be given according to the dosha dominance. In vata/ pitta/kapha dominant condition either Kalyanka gritha / Datryadi gritha or Mahat panchagavya gritha given respectively
9
Intervention Arm
Drug
Classical
(1) Medicine Name: Gandharvahastadhi Kashyam, Reference: Sahasrayogam 25/ 15-17, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 90(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Days, anupAna/sahapAna: No, Additional Information: -for rookshana prior to snehapana from 9th to 10th day
10
Intervention Arm
Drug
Classical
(1) Medicine Name: Shaddharanam gutika, Reference: Sahasrayogam 10/40-42, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Days, anupAna/sahapAna: Yes(details: -Kashaya), Additional Information: -on the 9th and 10th day of intervention for Rookshana prior to snehapana
(1) Medicine Name: Ashtachurna , Reference: Sahasrayogam 10/42, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 2 Days, anupAna/sahapAna: Yes(details: -takra), Additional Information: -churna will be given with 1.5 L of takra for two days(9th nad 10th day) for rookshana in Kaphadika condition. On those days kashaya will be given in evening time only
13
Intervention Arm
Procedure
-
AByantarasnehaH आ34र 5ेहः
(Procedure Reference: Ashtanga hridaya sootrasthana 11 th chapter, Procedure details: : from the 11th day onwards Aarohana matra snehapna will start as per agni and koshta of the patient till samayak snigdha lakshana.starting dose is 30 ml will given at 6 am.In vata/pitta/kapha dominant condition the gritha will be selected respectively as Kalyanaka gritha/Datryadi gritha/ Mahat panchagavya gritha)
14
Intervention Arm
Procedure
-
विरेचन-करà¥à¤®
(Procedure Reference: Ashtanga hridaya sootrasthana 18/33-45, Procedure details: on 20th day of intervention & medicine will be given at 6am with Luke warm water) (1) Medicine Name: Avipattichurnam, Reference: Sahasrayogam - churnaprakarana 47-48, Route: Oral, Dosage Form: Churna/ Powder, Dose: 25(g), Frequency: od, Duration: 1 Days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
50.00 Year(s)
Gender
Both
Details
Those fulfilling DSM V diagnostic criteria for SUD.
Those with mild to moderate symptoms as per DSM V
Age group between 18 to 50 years.
No discrimination of gender, religion and economic status.
Those fit for the protocol.
Those providing written consent.
ExclusionCriteria
Details
Diagnosed case of CAD, CLD, renal dysfunction and dyslipidaemia
Other psychiatric disorders
Ongoing psychiatric medication
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
To assess the effectiveness of an integrated protocol in Substance use disorder
The outcome will be assessed on 21st day of intervention
Secondary Outcome
Outcome
TimePoints
To assess the effectiveness of an integrated protocol on the quality if life the participants
The outcome will be assessed on the 21st day of intervention
Target Sample Size
Total Sample Size="18" Sample Size from India="18" 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 4
Date of First Enrollment (India)
01/01/2025
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
18 Participants are involved in this research. This study takes an integrated approach of Ayurvedic medicine along with contemporary treatments including behavioral therapy and Yoga. Each individual receives the selected treatment over a 21 day period. The effectiveness of the treatment will be evaluated on the first and last day of the treatment. The participants selected for the study will be instructed to receive the following treatment accordingly. For this period, participants will receive an integrated approach of Ayurvedic medicine along with contemporary treatments including Cognitive Behavioral therapy, Family counselling and Yoga. On the first day of treatment, Sadyo virechanam (mruduÅ›odhana) will be performed. For the next 7 days there will be Å›irodhÄra with UÅ›iÌ„ra Kashayam in the morning and Kachuradi CuÌ„rnÌ£a with KsÌ£iÌ„rabala Tailam as talam in the evening. Internal medications (Kharjuradi Mantha, Somalata CuÌ„rnÌ£a, Sarpagandha, Shweta Shankhapushpi, GokshuracuÌ„rnÌ£a, gritha administration ) will also be administered during this period. Later you have to receive the treatments such as RuÌ„ksÌ£anÌ£a, SnehapaÌ„nam, Virechanam etc. Yoga from the second day of the treatment, Cognitive Behavioral therapy in four secesions and family counseling are provided. The effectiveness of the treatment plan will be evaluating on the first day and on the 21st day.