| CTRI Number |
CTRI/2024/10/075819 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study The Effects Of Panchyagavya Ghrut Nasya And Ashwagandha Ghanvati On Nidranash |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study To Evaluate The Efficacy
Of Panchyagavya Ghrut Nasya Along With Ashwagandha Ghanvati
In Nidranash With Special Reference To 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 Shivaji Ankush Surwase |
| Designation |
PG Scholar |
| Affiliation |
Goverment Ayurvedic College , Nanded |
| Address |
Department of Kayachikitsa, Govt. Ayurved College And Hospital, Vazirabad, Nanded. Pin-431601. Landmark-Near S.P. Office
Nanded
MAHARASHTRA
431601
India |
| Phone |
08308435071 |
| Fax |
|
| Email |
shivajisurwase522@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh W Nalkande |
| Designation |
Assistant Professor |
| Affiliation |
Goverment Ayurvedic College , vazirabad nanded |
| Address |
Department Of Kayachikitsa, Govt. Ayurved College And Hospital, Vazirabad, Nanded. Pin-431601. Landmark-Near S.P. Office
Nanded
MAHARASHTRA
431601
India |
| Phone |
09766694490 |
| Fax |
|
| Email |
mwnalkande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh W Nalkande |
| Designation |
Assistant Professor |
| Affiliation |
Goverment Ayurvedic College , vazirabad nanded |
| Address |
Department Of Kayachikitsa, Govt. Ayurved College And Hospital, Vazirabad, Nanded. Pin-431601. Landmark-Near S.P. Office
Nanded
MAHARASHTRA
431601
India |
| Phone |
09766694490 |
| Fax |
|
| Email |
mwnalkande@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Ayurved College And Hospital, Vazirabad, Nanded. Pin-431601. Landmark-Near S.P. Office |
|
|
Primary Sponsor
|
| Name |
Dr Shivaji Ankush Surwase |
| Address |
Dept of kayachikitsa Govt. Ayurved College And Hospital, Vazirabad, Nanded. Pin-431601. Landmark-Near S.P. Office |
| 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 Shivaji Ankush Surwase |
Goverment Ayurvedic College Nanded |
Depatment Of Kayachikitsa,Govt. Ayurved College And Hospital, Vazirabad, Nanded. Pin-431601. Landmark-Near S.P. Office
Nanded
MAHARASHTRA |
08308435071
shivajisurwase522@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Govt . Ayu. College Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G470||Insomnia. 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 Ghanvati, Reference: Bhavprakash nighantu Guduchyadi varg 61-62, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 600(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: mahishdugha), Additional Information: - | | 2 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: Shushrut Samhita Chikitsashtana Adhyaya 40/52, Procedure details: nasya with panchygavya ghrut 2 drops in each nostril in evening for 15 days)
(1) Medicine Name: Ashwagnadha ghanvati, Reference: Bhavprakash nighantu, guduchyadi varg 161-162, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 600(mg), Frequency: hs, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient fulfilling the diagnostic criteria of study
2) Patient fit for Nasya.
3) Patients of either sex, aged between 18-60 years irrespective of caste, religion,
socio-economic and educational status.
4) Patient who had not participated in any research work since last one month will be
included.
|
|
| ExclusionCriteria |
| Details |
1. Acute illnesses such as cerebrovascular accidents, myocardial infarction, COPD,
epilepsy.
2. Nocturia due to any cause which may disturb sleep
3. Patients with major psychiatric illnesses like schizophrenia, depressive psychosis,
bipolar disorders, obsessive compulsive disorder, personality disorders, mood
disorders, panic disorders.
4. Thyroid disorders.
5. Advanced chronic illnesses such as bronchial asthma, cancer, chronic renal failure.
6. Pregnant women and lactating mother.
7. Patients who are currently participating in any other clinical trial from last 1
month. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Panchyagavya Ghrut Nasya along with
Ashwagandha Ghanvati in Nidranash by insomnia severity index. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Panchyagavya Ghrut Nasya along with
Ashwagandha Ghanvati on symptoms of Nidranash |
15 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/11/2024 |
| 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="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
|
This is randomized controlled open labelled clinical study of efficacy of panchyagavya ghrut nasya 2 drops in each nostril in evening along with ashwagandha ghanvati 600mg hs for 15 days. Ashawagandha ghanvati 600mg in hs for 15 days will be given in controlled group. This study is conducted as PG course at single centre. The primary outcome is to evaluate
the effect of panchyagavya ghrut nasya in nidranash with special reference to insomnia. |