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CTRI Number  CTRI/2024/08/072713 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 05/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A clinical intervention to evaluate the effect of bala shatavari medicated milk pouring procedure followed by ashwagandha powder and bala shatavari medicated milk pouring procedure followed by churna powder in adjustment disorder  
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of bala shatavari ksheeradhara followed by ashwagandha churna and bala-shatavari ksheeradhara followed by vacha churna in chittodvega vis-à-vis adjustment disorder  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jadhav Rina Arun 
Designation  Post Graduate scholar 
Affiliation  Sri kalabyraveshwaraswamy ayurvedic medical college Hospital and research centre 
Address  Room no 2 Sri kalabyraveshwaraswamy ayurvedic medical college Hospital and research centre vijayanagar bengaluru 560104
Room no 2 Department Of Kayachikitsa Sri kalabyraveshwaraswamy ayurvedic medical college Hospital and research centre vijayanagar bengaluru 560104
Bangalore
KARNATAKA
560104
India 
Phone  7972943244  
Fax    
Email  rinaaaaajadhav@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjunatha Adiga 
Designation  Professor 
Affiliation  Sri kalabyraveshwaraswamy ayurvedic medical college Hospital and research centre 
Address  Room no 2 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre Vijayanagar Bengaluru 560104
Room no 2 Department Of Kayachikitsa Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre vijayanagar bengaluru 560104
Bangalore
KARNATAKA
560104
India 
Phone  9035715798  
Fax    
Email  adiga.manjunatha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manjunatha Adiga 
Designation  Professor 
Affiliation  Sri kalabyraveshwaraswamy ayurvedic medical college Hospital and research centre 
Address  Room no 2 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre Vijayanagar Bengaluru 560104
Room no 2 Department Of Kayachikitsa Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre vijayanagar bengaluru 560104
Bangalore
KARNATAKA
560104
India 
Phone  9035715798  
Fax    
Email  adiga.manjunatha@gmail.com  
 
Source of Monetary or Material Support  
Sri Kalbyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre 10 Pipeline road RPC layout vijayanagar Bangalore 560104 
 
Primary Sponsor  
Name  Jadhav Rina Arun 
Address  Sri kalabyraveshwaraswamy ayurvedic medical college Hospital and research centre vijayanagar bengaluru560 104  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kiran M Goud  Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre   Vijayanagar Bengaluru 560104
Bangalore
KARNATAKA 		 9845109556

kiranmgoud@yahoo.co.in 
 
Details of Ethics Committee  
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F432||Adjustment disorders. Ayurveda Condition: MANOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ashwagandha, Reference: Bhava Prakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 14 Days, Reference: Yes, Route: water, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2Intervention ArmProcedure-SiraHsekaH, शिरःसेकः (Procedure Reference: Ayurvedic Treatment in Kerala , Dhara prakarana, Procedure details: Shirodhara with Bala Shatavari Ksheeradhara )
(1) Medicine Name: Bala Shatavari Ksheeradhara, Reference: Ayurvedic Treatment in Kerala , Dhara prakarana, Route: Topical, Dosage Form: Ksheerpaka, Dose: 1500(ml), Frequency: od, Duration: 7 Days
3Comparator ArmDrugClassical(1) Medicine Name: Vacha churna, Reference: Bhava Prakasha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 120(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: water), Additional Information: -
4Comparator ArmProcedure-SiraHpicuH, शिरःपिचुः (Procedure Reference: Ayurvedic Treatment in Kerala , Dhara prakarana, Procedure details: shirodhara with Bala Shatavari Ksheeradhara )
(1) Medicine Name: Bala shatavari ksheeradhara, Reference: Ayurvedic Treatment in Kerala , Dhara prakarana, Route: Topical, Dosage Form: Ksheerpaka, Dose: 1500(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects presenting with Udvega lakshana
Subjects presenting mild to moderate score in Adjustment Disorder - New Module 20
questionnaire
Subjects fit for Shirodhara Procedure
Subjects ready to sign informed consents and comply with study procedures 
 
ExclusionCriteria 
Details  Subjects with any systemic diseases that may interfere with the course of treatment
Subjects suffering from comorbid psychiatric disorders like chronic depression
psychosis personality disorder and medical intervention
Subject with history of chronic alcohol addiction
Subject with acute and chronic substance intoxication
Subject who cannot follow instructions to perform 
 
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 
To compare the Effect of Bala Shatavari ksheeradhara with Ashwagandha churna orally and Bala Shatavari ksheeradhara with Vacha churna orally in the management of Adjustment Disorder vis à vis Chittodvega  one and half year 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   23/09/2025 
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="5" 
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  

Adjustment Disorder is emotional response to stressors. Treatment includes psychotherapy, medication, and support. 
Ayurveda shows similar symptoms in the manasika vyadhi known as Chittodvega.
Imbalance in the rajas and tamas leads to the mental imbalance. Shirodhara treatment and Rasayana dravyas shows significant 
improvement in such conditions.  
Hence, This study comparesthe efficacy of Bala-Shatavari Ksheeradhara with Ashwagandha Churna and Vacha Churna in managing
 Adjustment Disorder.


 
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