| CTRI Number |
CTRI/2025/04/084398 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF KUSHMANDABEEJA KALKA AND YASTIMADHU CHURNA IN THE MANAGEMENT OF JARAJANYA VISHADA (GERIATRICS DEPRESSION) |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF KUSHMANDABEEJA KALKA AND YASTIMADHU CHURNA IN MANAGEMENT OF JARAJANYA VISHADA W.S.R GERIATRICS DEPRESSION |
| 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 SALONI |
| Designation |
PG SCHOLAR |
| Affiliation |
INSTITUTE FOR AYURVEDIC STUDIES AND RESEARCH FACULTY OF AYURVED SKAU KURUKSHETRA |
| Address |
Room No. 79 Department Of KAYACHIKITSA,INSTITUTE FOR AYURVEDIC STUDIES AND RESEARCH FACULTY OF AYURVED SKAU KURUKSHETRA SEC 8 UMRI ROAD KURUKSHETRA
Room No. 79 Department Of KAYACHIKITSA,INSTITUTE FOR AYURVEDIC STUDIES AND RESEARCH FACULTY OF AYURVED SKAU KURUKSHETRA SEC 8 UMRI ROAD KURUKSHETRA
Kurukshetra
HARYANA
136118
India |
| Phone |
9350965503 |
| Fax |
|
| Email |
ranasaloni08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Neelam Kumari |
| Designation |
Proffessor and Chairperson |
| Affiliation |
INSTITUTE FOR AYURVEDIC STUDIES AND RESEARCH FACULTY OF AYURVED SKAU KURUKSHETRA |
| Address |
ROOM NO. 56, DEPARTMENT Of KAYA CHIKITSA,INSTITUTE FOR AYURVEDIC STUDIES AND RESEARCH FACULTY OF AYURVED SKAU KURUKSHETRA SEC 8 UMRI ROAD KURUKSHETRA
ROOM NO. 56, DEPARTMENT Of KAYA CHIKITSA,INSTITUTE FOR AYURVEDIC STUDIES AND RESEARCH FACULTY OF AYURVED SKAU KURUKSHETRA SEC 8 UMRI ROAD KURUKSHETRA
Kurukshetra
HARYANA
136118
India |
| Phone |
9671368058 |
| Fax |
|
| Email |
mehranilam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SALONI |
| Designation |
PG SCHOLAR |
| Affiliation |
INSTITUTE FOR AYURVEDIC STUDIES AND RESEARCH FACULTY OF AYURVED SKAU KURUKSHETRA |
| Address |
ROOM NO.56 DEPARTMENT OF KAYACHIKITSA,INSTITUTE FOR AYURVEDIC STUDIES AND RESEARCH FACULTY OF AYURVED SKAU KURUKSHETRA SEC 8 UMRI ROAD KURUKSHETRA
ROOM NO. 56 DEPARTMENT OF KAYACHIKITSA,INSTITUTE FOR AYURVEDIC STUDIES AND RESEARCH FACULTY OF AYURVED SKAU KURUKSHETRA SEC 8 UMRI ROAD KURUKSHETRA
Kurukshetra
HARYANA
136118
India |
| Phone |
9350965503 |
| Fax |
|
| Email |
ranasaloni08@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE FOR AYURVEDIC STUDIES AND RESEARCH FACULTY OF AYURVED SKAU KURUKSHETRA SEC 8 UMRI ROAD KURUKSHETRA 136118 |
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR AYURVEDIC STUDIES AND RESEARCH |
| Address |
INSTITUTE FOR AYURVEDIC STUDIES AND RESEARCH FACULTY OF AYURVED SKAU KURUKSHETRA SEC 8 UMRI ROAD KURUKSHETRA 136118 |
| 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 |
| DR SALONI |
INSTITUTE FOR AYURVEDIC STUDIES AND RESEARCH |
ROOM NO 56 DEPARTMENT OF KAYACHIKITSA KURUKSHETRA HARYANA
Kurukshetra
HARYANA |
9350965503
ranasaloni08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI KRISHNA AYUSH UNIVERSITY KURUKSHETRA |
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:F068||Other specified mental disorders due to known physiological condition. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA), |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kushnandabeeja Kalka , Reference: Bhaisajya ratnavali unmaad chikitsa , Route: Oral, Dosage Form: Kalka/ Paste , Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yastimadhu Churna , Reference: Charak samhita chikitsa sthana chapter 1 part 3 verse 30,31, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Individuals over 60 years of age, regardless of their gender, religion, or vocation.
2 Individuals who had a score of greater than nine on the Geriatric Depression Scale
Participants who are open to participating in the research.
3 Subjects who are able to articulate their emotions clearly and who are not experiencing
psychosis |
|
| ExclusionCriteria |
| Details |
1 Participants who are younger than 60.
2 Subjects with a Geriatric Depression Scale score of less than nine points.
3 Participants who decline to participate in the research.
4 Individuals experiencing any kind of psychosis.
5 Subjects receiving medication for any systemic diseases and under any other
therapeutic regimen |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Alternation |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of Kushmandbeeja Kalka
in comparison to Yastimadhu Churna in the treatment of Jarajanaya Vishada(geriatric
depression). This will be assessed by measuring changes in the Geriatric Depression Scale (GDS) and Hamilton Depression Rating Scale scores, with the expectation of significant improvements in mental health and reduction in depression symptoms. |
30 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Improvements in emotional well-being, reduction in negative emotions, physical and mental growth, reduction in wasted time and resources, increased strength, reduction in weakness, enhanced cognitive performance , reduction in ignorance, and
overall improvement in quality of life. |
30 days |
|
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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)
|
23/06/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
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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
|
Depression is a common illness characterized by persistent sadness and a loss of interest in activities that one normally enjoys, accompanied by an inability to carry out daily activities, for at least two weeks. Growing older is a normal process. Among the many issues associated with ageing, one is geriatric depression. If untreated, though, it can result in severe depression. Depression in older persons may be exacerbated by age-related complications. These issues can include things like restricted movement, loneliness, dealing with death, retiring from the workforce, and having financial difficulties, extended drug misuse, friends’ and loved ones’ passing, divorce or widowhood.The dosha gets vitiated and localized in Hriday as a result of Manovaha Srotas causing Vishada. Plenty of clinical trial have been conducted on JarajanayaVishada but kushmandbeeja kalka is not trialed with Yashtimadhu Churna. Kushmandbeeja kalka is mentioned in classical text of ayurveda i.e.bhaisajya ratnavali .The content of drugs are kushmandbeej. Dravya is madhur, snighadha, shiit and medhya. Drug with these properties are useful to lower down the effect of vitiated vata and pitta dosha. Yastimadhu Churna is mentioned in Charak Samhita as Medhya rasayana. Medhya rasayana are used for treating maansik vikar. Enormous study have been done on Yastimadhu Churna for its efficacy as rasayana. Patients will be selected for this study based on their mental condition, which will be evaluated using specific clinical scales.
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