| CTRI Number |
CTRI/2025/04/085266 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness Of Jatamansi Phant And Padabhayanga W.S.R. To Stress Induced Nidranash |
|
Scientific Title of Study
|
A Comparative Analytical Study of Jatamansi Phant and Padabhyanga W.S.R.To Stress Induced Nidranash. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vandana Agrawal |
| Designation |
Pg Scholar |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved College GE Road Raipur Chhattisgarh |
| Address |
Department of Swasthvritta,Room no 05 Shri Narayana Prasad Awasthi Government Ayurved College GE Road Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
7987941721 |
| Fax |
|
| Email |
vandanaagrawal1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Sharma |
| Designation |
Professor & HOD Department Of Swasthvritta and Yoga |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved College GE Road Raipur Chhattisgarh |
| Address |
Department of Swasthvritta and Yoga Room no 01 Shri Narayana Prasad Awasthi Government Ayurved College GE Road Raipur Chhattisgarh
Department of Swasthvritta and Yoga Room no 01 Shri Narayana Prasad Awasthi Government Ayurved College GE Road Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827115211 |
| Fax |
|
| Email |
ansharma260@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sasmita Tripathy |
| Designation |
Reader Department of Swathvritta and Yoga |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved College GE Road Raipur Chhattisgarh |
| Address |
Department of Swasthvritta and Yoga Room no 02 Shri Narayana Prasad Awasthi Government Ayurved College GE Road Raipur Chhattisgarh
Department of Swasthvritta and Yoga Room no 02 Shri Narayana Prasad Awasthi Government Ayurved College GE Road Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
8763650383 |
| Fax |
|
| Email |
sasmita1980@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Swashthavritta and Yoga Shri Narayan Prasad Awasthi Government Ayurvedic College Raipur Chhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Department of Swashthavritta and Yoga Government Ayurvedic College Raipur Chhattisgarh 492010 |
| Address |
Shri Narayan Prasad Awasthi Government Ayuvedic College Raipur Chhattisgarh 492010 |
| Type of Sponsor |
Other [Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh |
Shri Narayan Prasad Awasthi Government Ayurvedic College Raipur Chhattisgarh 492010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vandana Agrawal |
Shri Khudadad Doongaji Government Ayurvedic College Chhattisgarh 492010 Raipur Chhattisgarh |
Department of Swasthvritta and yoga OPD 6 and IPD patient
Raipur
CHHATTISGARH |
07987941721
vandanaagrawal1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVED COLLEGE RAIPUR CHHATTISGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F488||Other specified nonpsychotic mental disorders. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: jatamansi, Reference: priya nighantu, Route: Oral, Dosage Form: Phanta, Dose: 18(ml), Frequency: hs, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Procedure | - | EkA~gga, एकांग | (Procedure Reference: Dr G Shrinivasha acharya page no 126-130, Procedure details: application of the til tail oil followed by different maneurs. warm til tail oil is smeared to the feet in its plantar & dorsal aspect upto ankle in evening for 10 minutes.)
|
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient age is 18-60 years,irrespective of gender,religion,marital status,socioeconomic status.
2.Patient having sign and symptoms of Nidranash.
3.Patient willing to Participate.
4.Patient Coming Under mild and moderate range of perceived stress scale. |
|
| ExclusionCriteria |
| Details |
1.Individual below 18 years and above 60 years of age.
2.Patient with know case of uncontrolled Diabetes,Foot ulcer,Psoriasis,any external injuries over foot and uncontrolled hypertension and thyroid.
3.Individual who have addiction of tobacco and drinks.
4.Day sleepes, person who works in nightshift.
5.Patient coming under high range of perceived stress scale.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improve the quality of sleep |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve the quality of life |
60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/05/2025 |
| 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="0"
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
|
In Charak Samhita there is description of Nidranash in Chapter intitled Ashtauninditiya Adhyaya ,In Priya Nighantu there is description of Jatamansi in Shatpushpadi Varga for Nidranash. Jatamansi Phant will be prepared by using Jatamansi Churna and water.Jatamansi Phant given to Patient for 2 month.Patient selected will be age of 18-60 years,irrespective of gender,religeon,marital status,socioeconomic status,Patient having Sign and symptoms of Nidranash,Patient willing to paricipate ,Patient coming under mild and moderate range of perceived stress scale.Patient suffering from Diabetes mellitus,Psoriasis.any external injuries over foot,who have addiction of tobacco and drinks,patient coming under high range of perceived stree scale and day sleepers, Finally patient will be asses on the basis of subjective and objective parameters and conclusion will be drawn.
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