| CTRI Number |
CTRI/2023/02/049595 [Registered on: 09/02/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the efficacy of Shankhpuspi Churna and Mansyadi Kwath in Anidra (Insomnia) |
|
Scientific Title of Study
|
Randomized Controlled Study to compare the efficacy of
Shankhpushpi Churna and Mansyadi Kwath in Anidra [Insomnia]
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nazia Irshad |
| Designation |
MD Scholar (Department of kayachikitsa) |
| Affiliation |
Ch. Brahm Prakash Ayurveda Charak Sansthan |
| Address |
Ch. Brahm Prakash Ayurved Charak Sansthan, khera
dabar Najafgrah Delhi
South West
DELHI
110073
India
South West
DELHI
110073
India |
| Phone |
8130100686 |
| Fax |
|
| Email |
naz.zia.irsh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr N R SINGH |
| Designation |
Head of Department |
| Affiliation |
Ch. Brahm Prakash Ayurveda Charak Sansthan |
| Address |
Room no 153 First floor Department of Kayachikitsa Ch. Brahm Prakash Ayurved Charak Sansthan, khera
dabar Najafgrah Delhi
South West
DELHI
110073
India
South West
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nazia Irshad |
| Designation |
MD Scholar (Department of kayachikitsa) |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch. Brahm Prakash Ayurved Charak Sansthan, khera
dabar Najafgrah Delhi
South West
DELHI
110073
India
South West
DELHI
110073
India |
| Phone |
8130100686 |
| Fax |
|
| Email |
naz.zia.irsh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch Brham Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch. Brahm Prakash Ayurved Charak Sansthan khera Dabar
Najafgarh New Delhi |
| 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 |
| Nazia Irshad |
Ch. Brahm Prakash Ayurved Charak Sansthan |
Room no 153 First floor Department of Kayachikitsa Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi 110073
South West
DELHI |
8130100686
naz.zia.irsh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F510||Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sankhpuspi Churna, Reference: Parul agarwal, An update on ayurvedic herb convolvulus pluricaulis choisy, Asian pacific journal of tropical biomedicine, vol - 4 , issue - 3, page no-245-252,2014., Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mansyadi Kwath, Reference: Siddhayoga Sangraha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient suffering from insomnia since last one month and up to 2 years.
2.Patient having complained of insomnia at least 3 nights a week or more.
3. Patient who are able to take medicine orally.
|
|
| ExclusionCriteria |
| Details |
1.Patient having complaint of insomnia less than one month and more than 2 years.
2.Patient suffering from any major systemic and psychiatric illness which may affect the sleeping condition of patient.
3.Patient already taking medicine for sleeping illness.
4.Pregnant and lactating women.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OUTCOME MEASURE: Reduction in PSQI score.
|
Day 0, Day 1, Day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Quality of Life in terms of improving clinical features of Insomnia as per classical texts. 1.Body Ache
2.Heaviness in head 3.Yawning 4.Stiffness 5.Mental despair 6.Dizziness 7.Improper Digestion 8.Lethargy
|
Day 0, Day 1, Day 45 |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2023 |
| Date of Study Completion (India) |
23/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Insomnia is a sleep disorder where people experience difficulty in sleeping or inadequate, poor-quality sleep. They may have trouble falling asleep, waking up frequently during the night with difficulty returning to sleep, and waking up too early in the morning. However, insufficient sleep increases the risk of numerous lifestyle-related diseases and impairs working capacity and concentration. In Ayurveda classics, described that person who take proper sleep in proper time can achieve healthy state of mind as well as good complexion and virility in addition of longevity. A careful review of the Ayurvedic medical literature reveals that increased Vata, old age, habit, and indulgence in work are the main causes of the Anidra (sleeplessness). In Ayurvedic literature, terms for insomnia include Anidra, Nidranasha, and Asvapna.Total no of patients: 30, 15 in each group, In Group A, Mansyadi Kwath is given in dose of 40ml at night before meal. In Group B, Shankhpushpi churna is given in dose of 5gm with lukewarm water at night before meal. Study design is single centered, open label, randomized, interventional type, comparative study. |