| CTRI Number |
CTRI/2021/12/038595 [Registered on: 13/12/2021] Trial Registered Prospectively |
| Last Modified On: |
11/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Role of Saraswata Churna and Ashwagandha Ghrita in the management of depressive disorder (Undmada) |
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Scientific Title of Study
|
An Open Randomized Control Clinical study on efficacy of Saraswata Churna and Ashwagandha Ghrita in the management of Kaphaja Unmada w.s.r. depressive disorders
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaidya Sandeep Aggarwal |
| Designation |
Phd Scholar |
| Affiliation |
Shri Krishna AYUSH University |
| Address |
Room No 55 56 Ground Floor Department of Kayachikitsa Shri Krishna AYUSH University Kurukshetra Haryana
Kurukshetra HARYANA 136118 India |
| Phone |
9319577700 |
| Fax |
|
| Email |
dhanwantri211@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Balbir Singh Sandhu |
| Designation |
Professor |
| Affiliation |
Shri Krishna AYUSH University |
| Address |
Room No 55 56 Ground Floor Department of Kayachikitsa Shri Krishna AYUSH University Kurukshetra Haryana
Kurukshetra HARYANA 136118 India |
| Phone |
9813063424 |
| Fax |
|
| Email |
balbirsandhu63@gmail.com |
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Details of Contact Person Public Query
|
| Name |
Prof Balbir Singh Sandhu |
| Designation |
Professor |
| Affiliation |
Shri Krishna AYUSH University |
| Address |
Room No 55 56 Ground Floor Department of Kayachikitsa Shri Krishna AYUSH University Kurukshetra Haryana
HARYANA 136118 India |
| Phone |
9813063424 |
| Fax |
|
| Email |
balbirsandhu63@gmail.com |
|
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Source of Monetary or Material Support
|
| Shri Krishna AYUSH University Kurukshetra Haryana |
|
|
Primary Sponsor
|
| Name |
Shri Krishna AYUSH University |
| Address |
Ground Floor Department of Kayachikitsa Shri Krishna AYUSH University Kurukshetra Haryana |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sandeep Aggarwal |
Shri Krishna AYUSH University |
Ground Floor Department of Kayachikitsa Shri Krishna AYUSH University Kurukshetra Haryana Kurukshetra HARYANA |
9319577700
dhanwantri211@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
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:F330||Major depressive disorder, recurrent, mild. Ayurveda Condition: KAPHAJA UNMADAH, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Saraswata Churna, Reference: Bhaishjya Ratnawali 26,27,28,29 pg. no. 513, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Madhu & Ghrita), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Ghrita, Reference: Bhaishajaya Ratnavali 26 Adhyaya Vatavyadhi Chikitsa 26/220, Route: Oral, Dosage Form: Ghrita, Dose: 6(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Sukhoushna Jala (Lukewarm water)), Additional Information: |
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Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Age groups 30-75 years of either sex, no discrimination of caste and religion
2 Hamilton’s Depression Rating Scale and Ayurvedic Assessment Scale in Kaphaja Unmada
diagnostic criteria for mood disorder due to general medical Condition of Unmada with
depressive features. |
|
| ExclusionCriteria |
| Details |
1 Patient with a history of hereditary or previous mental disorders
2 Unconscious & coma patients
3 Intracranial infections such as Meningitis
4 Space occupying lesions of the brain such as tumours
5 Stroke due to RTA, Traumas
6 Congenital defects- diffuse sclerosis, cerebral agenesis, etc. & other major illness
7 Events promoting depression other than the impact of Kaphaja Unmada
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To rule out the significant result of Saraswata Churna and Ashwagandha Ghrita in the management of Kaphaja Unmada w.s.r. depressive disorders |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To rule out the significant result of Saraswata Churna in the management of Kaphaja Unmada w.s.r. depressive disorders |
8 weeks |
| To rule out the significant result of Ashwagandha Ghrita in the management of Kaphaja Unmada w.s.r. depressive disorders |
8 weeks |
|
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Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
13/12/2021 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
not yet |
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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
|
BRIEF SUMMARY ON PURPOSE -
Kaphaja Unmada is a common cause of depression in today’s era. Unmada further deceives the eligibility for the patient to become normal in his life. This event not only changes the patient but its environment leading to harm at Social, Physiological & at Physical levels. Contemporary science focuses on the suppression of depression but comparatively, Ayurveda focuses on treating the cause. So, it is a humble effort to manage Unmada through Ayurveda by conducting this clinical trial for the betterment of human beings.
BACKGROUND OF TRIAL- it is an interventional Study
Randomized Patients with a written consent form for the study will be selected. The Patients will be divided into three groups (irrespective of Gender, Cast, Religion,) in Group A - 40 and Group B – 40, Group c – 40). To Assess the Efficacy of Sleep in Group A (Saraswati Churna) and Group B ( Ashwagandha Ghrita) and Group C (Both Saraswati Churna + Ashwagandha Ghrita) Randomly selected Patients with the help of hamilton’s Depression Rating Scale and Ayurvedic Assessment Scale in Kaphaja Unmada diagnostic criteria will be taken. The Patients were advised for 4 gm Saraswata Churna with Madhu / Ghrita and Ashwagandha Ghrita 3-6 ml with lukewarm water were collected for a period of 2 months (60 days). After all these procedures follow up will be taken and an Assessment is done with the help of hamilton’s Depression Rating Scale and Ayurvedic Assessment Scale in Kaphaja Unmada diagnostic criteria.
Finding - There will be a Significant effect of Saraswata Churna and Ashwagandha Ghrita in the management of Kaphaja Unmada w.s.r. depressive disordersâ€
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