| CTRI Number |
CTRI/2025/04/083928 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical interventional study to evaluate the efficacy of Gud-Pippalimool tablet and Ashwagandha tablet in the management of Nidranash in Healthy Volunteers (Patients) |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the efficacy of Gud-Pippalimool tablet and Ashwagandha tablet in the management of Nidranash w.r.t 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 Tanya Bhawnani |
| Designation |
PG Scholar |
| Affiliation |
Padmashree Dr DY Patil School of Ayurveda , Nerul ,Navi Mumbai |
| Address |
DY Patil School of Ayurveda,First floor opd no. 1,Dept of Kayachikitsa,Sector 7 Nerul, Navi Mumbai,Thane
DY Patil School of Ayurveda,Third floor,Dept of Kayachikitsa,Sector 7 Nerul, Navi Mumbai,Thane
Thane
MAHARASHTRA
400706
India |
| Phone |
7805913223 |
| Fax |
|
| Email |
drtanyabhawnani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanya Bhawnani |
| Designation |
PG Scholar |
| Affiliation |
Padmashree Dr DY Patil School of Ayurveda , Nerul ,Navi Mumbai |
| Address |
DY Patil School of Ayurveda,First floor opd no. 1,Dept of Kayachikitsa,Sector 7 Nerul, Navi Mumbai,Thane
DY Patil School of Ayurveda,Third floor,Dept of Kayachikitsa,Sector 7 Nerul, Navi Mumbai,Thane
Thane
MAHARASHTRA
400706
India |
| Phone |
7805913223 |
| Fax |
|
| Email |
drtanyabhawnani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dnyaneshwar M Padavi |
| Designation |
Head of Department |
| Affiliation |
Padmashree Dr DY Patil School of Ayurveda , Nerul ,Navi Mumbai |
| Address |
DY Patil School of Ayurveda,Third floor,Dept of Kayachikitsa,Sector 7 Nerul, Navi Mumbai,Thane
DY Patil School of Ayurveda,Third floor,Dept of Kayachikitsa,Sector 7 Nerul, Navi Mumbai,Thane
Thane
MAHARASHTRA
400706
India |
| Phone |
9833158688 |
| Fax |
|
| Email |
dmpadavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| DY Patil School of Ayurveda,Sector 7,Nerul ,Navi Mumbai- 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Tanya Bhawnani |
| Address |
DY Patil School of Ayurveda,Sector 7,Nerul ,Navi Mumbai |
| Type of Sponsor |
Other [self] |
|
|
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 Tanya Bhawnani |
DY Patil Deemed to be university school of Ayurveda |
1st Floor, OPD no. 1, Department of Kayachikitsa, D. Y. Patil University school of Ayurveda, Sector 7, Nerul, Navi Mumbai-400706.
Thane
MAHARASHTRA
Thane
MAHARASHTRA |
7805913223
drtanyabhawnani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee of School of Ayurveda, D.Y. Patil Deemed to be University, Neru, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G968||Other specified disorders of central nervous system. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Tablet, Reference: Vang Sen Chikitsa Jaldoshadi Yogadhikar 13, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gud-Pippalimool, Reference: Bhav Prakash Chikitsa 1.326, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1-Patients complaining of difficulty in falling asleep, frequent or sustained awakenings and early morning awakenings.
2-patients suffering from insomnia from one month or above.
|
|
| ExclusionCriteria |
| Details |
1-Patients with major psychiatric illness like schizophrenia, depressive psychosis, epilepsy, etc
2-Patients with drug dependency.
3-Women in their pregnancy and lactation.
4-Chronic alcoholic patients.
5-Diabetic patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The drug may help to bring Improvement in sleep Quality and duration |
total 28 days study
Follow up on 14th day 28th day & 14 days
after the completion of treatment.
|
|
|
Secondary Outcome
|
|
|
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)
|
10/04/2025 |
| 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 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
|
Title: Comparative Clinical Study to evaluate the efficacy of Gud-Pippalimool tablet and Ashwagandha Tablet in the Management of Nidranash w.r.t Insomnia Aim: To compare the efficacy of Gud-Pippalimool tablet and Ashwagandha tablet in the management of Nidranash w.r.t Insomnia. Objectives: 1. To study the effect of Gud-Pippalimool tablet in management of Insomnia. 2. To study insomnia in detail according to Ayurveda and modern science. 3. To compare the effects of Gud-Pippalimool tablet and Ashwagandha tablet in the management of insomnia. Research Questions: Primary Research Question - Is Gud-Pippalimool tablet effective in the management of Nidranash w.r.t Insomnia? Secondary Research Question - Is the effect of Gud-Pippalimool tablet significant than Ashwagandha tablet in the management of Nidranash w.r.t Insomnia? Hypothesis: H0: There will be no significant difference between Gud-Pippalimool tablet and Ashwagandha tablet in the management of Nidranash w.r.t Insomnia. H1: There will be significant difference between Gud-Pippalimool tablet and Ashwagandha tablet in the management of Nidranash w.r.t Insomnia. Materials: Group A (Gud-Pippalimool tablet) - Contents: Pippali, Pippali Mool and Gud (Jaggery). Group B (Ashwagandha Tablet) - Contents: Ashwagandha churna, Sita (sugar) and Sarpi (ghee). Drug Administration: Gud-Pippalimool tablet 2gm HS with water for 28 days by oral route and Ashwagandha tablet 2gm HS with water for 28 days by oral route. Methods: Study Design - Two arms, Open labelled, Randomized and Controlled clinical study. Assessment Criteria: Subjective Criteria
1. | Symptom | 0 Grade | 1 Grade | 2 Grade | 3 Grade | | Jrumbha | Never | Occasionally | Periodically | Always | | Angamarda | Never | Occasionally | Periodically | Always | | Tandra | Never | Occasionally | Periodically | Always | | Shirogaurav | Never | Occasionally | Periodically | Always |
2. Pittsburgh Sleep Quality Index (PSQI)
1) All observation will be noted in the observation table. 2) Depending upon observation, Statistical analysis will be done by appropriate test. 3) Efficacy of Subjective criteria will be analyzed by Wilcoxon rank sum test. 4) Efficacy of Objective criteria will be analyzed by paired t-test. |