| CTRI Number |
CTRI/2023/08/057101 [Registered on: 30/08/2023] Trial Registered Prospectively |
| Last Modified On: |
30/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Check The Effect Of Jatamansi And Ashwagandha In The Management Of Sleeplessness |
|
Scientific Title of Study
|
A Pharmaco Clinical Comparative Study Of Jatamansi (Nardostachys jatamansi DC.) and Ashwagandha (Withania somnifera Dunal) Moola Churna In The Management Of Anidra (Insomnia ) |
| 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 Gurpreet sama |
| Designation |
PG scholar |
| Affiliation |
post graduate training and research institute Government Ayurvedic college and hospital |
| Address |
PG Dravyaguna department, post graduate training and research institute Government Ayurvedic college
Patiala
PUNJAB
147001
India |
| Phone |
9915635190 |
| Fax |
|
| Email |
drgurpreetsama07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankita |
| Designation |
Lecturer |
| Affiliation |
post graduate training and research institute Government Ayurvedic college and hospital |
| Address |
PG Dravyaguna department, post graduate training research institute Government Ayurvedic college
Patiala
PUNJAB
147001
India |
| Phone |
9417679849 |
| Fax |
|
| Email |
ankita.goyal07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita |
| Designation |
Lecturer |
| Affiliation |
post graduate training and research institute Government Ayurvedic college and hospital |
| Address |
PG Dravyaguna department, post graduate training and research institute Government Ayurvedic college
Patiala
PUNJAB
147001
India |
| Phone |
9417679849 |
| Fax |
|
| Email |
ankita.goyal07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Training and Research Institute Govt. Ayurvedic College |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College |
| Address |
Government Ayurvedic College, Moti Bhagh, Patiala |
| Type of Sponsor |
Government 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 Gurpreet Sama |
Government Ayurvedic Hospital, Patiala |
Room no. 7, Ground floor Department of Kayachiktsa, Government Ayurvedic Hospital, Patiala
Patiala
PUNJAB |
9915635190
drgurpreetsama07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Government Ayurvedic College Patiala, No,4685 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. 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, Reference: API, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: LUKE WARM WATER), Additional Information: 2gm churna(daily dose) will be filled in capsule of 500mg each making a total 0f 4 capsule of 500mg each as daily dose will be given to the patient after having dinner in night with luke warm water.The capsules are preferd for the convenience of the patient. the ref of the drug is in API Vol. I, Pg. No. 52 for Anidra/ Nidranasha(2) Medicine Name: Ashwagandha, Reference: Raj nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: luke warm wa), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with written consent. 2)Patients having clinical features of Anidra as Angamarda, Shirogaurava, Jrambhika, Bhrama, Tandra, Jadyata.3) Patients with computer, mobile screening time less than 6 hours. |
|
| ExclusionCriteria |
| Details |
1)Patients below the age of 18 Years and above the age of 60 years. 2) pregnant and lactating mothers. 3) Patients with history of any serious systemic illness hyper/hypo tension. 4)patients taking medications like antidepressants, sleeping pills 5) Patients with computer, mobile screening time more than 6 hours. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subjective Parameter: Grading will be done with sign & symptoms of Anidra Hb TLC DLC SGOT/PT Serum Creatinine |
At start of the trial and after 1 month of intervention of Ashwagandha powder & jatamansi powder, last follow up after 7 days of stopping medicine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective Parameter Grading will be done with sign & symptoms of Anidra Hb TLC DLC |
At start of the trial & after 1 month of intervention of Ashwagandha powder & jatamansi powder, last followup after 7 days of stopping the medicine. |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/09/2023 |
| 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="0"
Months="1"
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 this trial we are selecting patients of Anidra in two groups, in which we will do intervention study of drug Ashawagandha mool choorana and jatamansi mool choorana in the form of capsule with the dose of 2 gm OD at night with luke warm water . Assessment will be done on the subjective parameters for anidra disease. Route of administration: Oral Follow up : Day 15, Day 30, Day 37 |