| CTRI Number |
CTRI/2022/11/047445 [Registered on: 21/11/2022] Trial Registered Prospectively |
| Last Modified On: |
19/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Churna for Oral Use and Taila Padabhyanga] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Nidranasha by Jatamansi Churna and Nirgundi Taila Padabhyanga |
|
Scientific Title of Study
|
A Study on Nidra and evaluation of the effect of Jatamansi Churna and Nirgundi Taila Padabhyanga in Nidranasha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manasi Pradhan |
| Designation |
PG Scholar |
| Affiliation |
Govt Ayurvedic College and Hospital Balangir |
| Address |
PG Department of Ayurveda Samhita and Siddhanta
Govt Ayurvedic College and Hospital Balangir
PG Department of Ayurveda Samhita and Siddhanta
Govt Ayurvedic College and Hospital Balangir
Balangir
ORISSA
767001
India |
| Phone |
7008100658 |
| Fax |
|
| Email |
manasipradhanmay24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Arun Ku Das |
| Designation |
Principal |
| Affiliation |
Govt Ayurvedic College and Hospital Balangir |
| Address |
Principal Govt Ayurvedic College and Hospital Balangir
Principal Govt Ayurvedic College and Hospital Balangir
Balangir
ORISSA
767001
India |
| Phone |
9861229623 |
| Fax |
|
| Email |
dasarun1969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Arun Ku Das |
| Designation |
Principal |
| Affiliation |
Govt Ayurvedic College and Hospital Balangir |
| Address |
Principal Govt Ayurvedic College and Hospital Balangir
Principal Govt Ayurvedic College and Hospital Balangir
Balangir
ORISSA
767001
India |
| Phone |
9861229623 |
| Fax |
|
| Email |
dasarun1969@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manasi Pradhan, PG Department of Ayurveda Samhita and Siddhanta Govt Ayurvedic College and Hospital, Balangir |
|
|
Primary Sponsor
|
| Name |
Manasi Pradhan |
| Address |
PG Department of Ayurveda Samhita and Siddhanta
Govt Ayurvedic College and Hospital Balangir |
| Type of Sponsor |
Other [Govt Ayurvedic College and Hospital Balangir] |
|
|
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 |
| Prof Dr Arun Ku Das |
Govt Ayurvedic College and Hospital Balangir |
OPD and IPD of Govt Ayurvedic College and Hospital And Saradeswari Govt Ayurvedic Hospital Balangir
Balangir
ORISSA |
9861229623
dasarun1969@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVT AYURVEDIC COLLEGE AND HOSPITAL BALANGIR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z00-Z99||Factors influencing health status and contact with health services. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatamansi Churna, Reference: Priya Nighantu (Shatapuspadi Varga), Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Shitala Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nirgundi Taila, Reference: Charaka Chikitsa , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Nirgundi Taila For Padabhyanga. |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having Nidranasha as per clinical sign and symptoms as in classical text.
2.Patients of both the sex in the age between 30-70 yrs.
3.Patients without any systemic disorders.
4.Patient is having difficulty in initiating sleep even after one hour.
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from other systemic illness and metabolic disorders.
2.Patients of both sex in the age below 30 and above 70 years.
3.Patient who are on psychiatric treatment.
4.Accident cases, post-operative cases, drug abuser, alcohol addicted, mentally retarded and psychiatric abnormalities, pregnant and lactating mother.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To control the symptoms of Nidranasha by the internal application of Jatamansi Churna. |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Internal application Jatamansi Churna and Nirgundi Taila Padabhyanga are more effective than the internal application of Jatamansi Churna in Nidranasha. |
15 Days |
|
|
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 1 |
|
Date of First Enrollment (India)
|
22/11/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The study will be submitted in the form of dissertation to Sambalpur University as a part of Post Graduate study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a study on Nidra and evaluation of the effect of Jatamansi Churna and Nirgundi Taila Padabhyanga in Nidranasha. This is done compulsory part of Post Graduate Course. Total No. of patients to be studied is 40 with duration of 15 days |