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CTRI Number  CTRI/2025/08/092244 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Creating a Standardized Assessment Tool for Monitoring Langhana Therapy Effectiveness in Traditional Ayurvedic Treatments 
Scientific Title of Study   Development of scale for standardized assessment of samyak langhita lakshana in subjects undergoing langhana therapy in the form of shodhanapurvaka pachana,deepana. 
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 DEEPA JAVALI 
Designation  PG SCHOLAR 
Affiliation  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN. 
Address  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, TANNIRUHALLA, BM ROAD, HASSAN , KARNATAKA. Dept of Ayurveda samhita and siddhanta
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, TANNIRUHALLA, BM ROAD, HASSAN , KARNATAKA Dept of Ayurveda samhita and siddhanta
Hassan
KARNATAKA
573201
India 
Phone  8618578041  
Fax    
Email  deepasjavali1999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR RAJA RAJESHWARI N M 
Designation  MD (Ayu) 
Affiliation  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN. 
Address  Department of Ayurveda samhita and siddhanta, 3rd floor SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, TANNIRUHALLA, BM ROAD, HASSAN , KARNATAKA.
Department of Ayurveda samhita and siddhanta, 3rd floor SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, TANNIRUHALLA, BM ROAD, HASSAN , KARNATAKA.
Hassan
KARNATAKA
573201
India 
Phone  9964586059  
Fax    
Email  drrajarajeshwari@sdmcahhassan.org  
 
Details of Contact Person
Public Query
 
Name  DR DEEPA JAVALI.  
Designation  PG SCHOLAR. 
Affiliation  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN. 
Address  Department of Ayurveda samhita and siddhanta, 3rd floor. SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, TANNIRUHALLA, BM ROAD, HASSAN , KARNATAKA
Department of Ayurveda samhita and siddhanta, 3rd floor. SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, TANNIRUHALLA, BM ROAD, HASSAN , KARNATAKA
Hassan
KARNATAKA
573201
India 
Phone  8618578041  
Fax    
Email  deepasjavali1999@gmail.com  
 
Source of Monetary or Material Support  
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, TANNIRUHALLA, BM ROAD, HASSAN , KARNATAKA  
 
Primary Sponsor  
Name  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN , KARNATAKA  
Address  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, TANNIRUHALLA, BM ROAD, HASSAN , KARNATAKA  
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 DEEPA JAVALI  Sri Dharmasthala manjunatheshwara college of ayurveda and hospital  Dept- Ayurveda Samhita and siddhanta. TANNIRUHALLA,BM ROAD,HASSAN,KARNATAKA-573201
Hassan
KARNATAKA 
8618578041

deepasjavali1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, TANNIRUHALLA, BM ROAD, HASSAN , KARNATAKA   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects who are administered with, Pachana, Deepana (irrespective of disease except which mentioned in exclusion criteria.)
2. Subjects of both gender and willing to give consent.
3. Subjects between the age group of 18-60 years.
 
 
ExclusionCriteria 
Details  1. Subjects incapable to give valid responses.
2. Subjects who are contraindicated for Langhana mentioned in the texts of Ayurveda.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Development of a Questionnaire to Assess Samyak Langhita Lakshana.
2. Clinical Application of the Questionnaire in Subjects Undergoing Langhana Therapy. 
18 months for full study 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   20/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/08/2025 
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  

NEED FOR STUDY:

The parameters used in Ayurveda are always associated with a certain amount of subjectivity and hence vary from one physician to the other. There is lack of uniform method of assessment of these parameters leading to vague questioning by physician and vague perception by subjects leading to inappropriate response. Hence this study is taken up to develop a scale for a standardized assessment of Samyak Langhita Lakshana   in subjects undergoing Langhana therapy  in the form of Shodhanapurvaka Pachana ,Deepana

OBJECTIVE:   To develop scale for standardised assessment of Samyak Langhita Lakshana.

 

METHODOLOGY:       

INCLUSION CRITERIA

·       Subjects who are administered with Pachana,Deepana (irrespective of disease except which mentioned in exclusion criteria.)

·       Subjects of both gender and willing to give consent

·       Subjects between the age group of 18-60 years.

 

EXCLUSION CRITERIA

·       Subjects incapable to give valid responses.

·       Subjects  who are  contraindicated for  Langhana  mentioned in the texts of Ayurveda

 

PLAN OF STUDY:

·       Subjects who fulfill the inclusion criteria will be selected for the study and data will be collected using the questionnaire prepared on Samyak Langhita Lakshana as mentioned in texts of Ayurveda.

·       Questionnaires sent to experts and content validity is done.

·       Pilot study done on 30 patients.

·       Samyak Langhita Lakshana  assessed  thrice  daily  i.e Morning, Afternoon, Evening  throughout the course of  Pachana, Deepana

·       Study is conducted on actual sample.

 

 

Study Type: Survey study.

Time perspective: Cross sectional.

Sample size:  100

 

TESTS USED:

·       Cronbach’s alpha test.

·       KMO test

·       Bartlett test 

 

REFERENCE FOR METHODOLOGY:

 Boateng GO, Neilands TB, Frongillo EA, Melgar- Quinonez HR and Young SL. Best practices for Developing and Validating Scales for Health, Social, and Behavioral Research:A Primer.Front.Public Health 6:149(2018 Pg no 5-15.)

 
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