| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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.) |