| CTRI Number |
CTRI/2023/05/052304 [Registered on: 04/05/2023] Trial Registered Prospectively |
| Last Modified On: |
07/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Open label |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pulse Examination in different body constitution individuals having Good Digestive power & Weak Digestive power. |
|
Scientific Title of Study
|
An observational study of Nadi in different Deha Prakriti individuals with special reference to Diptagni & Mandagni |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meha Sharma |
| Designation |
PG Scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College and Hospital |
| Address |
Room No. 26, PG Department of Kriya Sharir, Shri Krishna Govt. Ayurvedic College and Hospital, Umri Road, Sector-8, Kurukshetra
Umri Road, Sector-8, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8307446258 |
| Fax |
|
| Email |
sharma07meha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meha Sharma |
| Designation |
PG Scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College and Hospital |
| Address |
Room No. 26, PG Department of Kriya Sharir, Shri Krishna Govt. Ayurvedic College and Hospital, Umri Road, Sector-8, Kurukshetra
Umri Road, Sector-8, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8307446258 |
| Fax |
|
| Email |
sharma07meha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meha Sharma |
| Designation |
PG Scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College and Hospital |
| Address |
Room No. 26, PG Department of Kriya Sharir, Shri Krishna Govt. Ayurvedic College and Hospital, Umri Road, Sector-8, Kurukshetra
Umri Road, Sector-8, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8307446258 |
| Fax |
|
| Email |
sharma07meha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Govt Ayurvedic College and Hospital, Kurukshetra, Haryana-136118 |
|
|
Primary Sponsor
|
| Name |
Shri Krishna Govt Ayurvedic College and Hospital, Kurukshetra |
| Address |
Umri Road, Sector-8, Kurukshetra |
| 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 |
| Dr P C Mangal |
Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra |
Room No 61A, PG Department of Kriya Sharir, Shri Krishna Govt. Ayurvedic College and Hospital, Umri Road, Sector 8, Kurukshetra
Kurukshetra
HARYANA |
9416159505
PMANGLA69@YAHOO.COM |
|
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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:K929||Disease of digestive system, unspecified. Ayurveda Condition: AJIRNAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Both male & female individuals.
Age between 16 to 40 years.
Subjects with Mandagni.
Subjects with Diptagni (Tikshnagni). |
|
| ExclusionCriteria |
| Details |
Subject below 16 years & above 40 years of age will be excluded.
Just after bath/ waking up/ food intake/ oil massage/ sunbath/ exercise/ chronic illness/
sexual intercourse.
One who is hungry/ thirsty/ asleep.
Individuals with Samagni/ Vishamagni.
Hospitalised Patients on Life Supports.
Subject with / Comorbid Disorders.
History of Cardiovascular disorder.
Subject with Psychic diseases on medications.
History of Major surgery in the recent past.
History of Drug intake. (Corticosteroids/ sleep medications etc.)
History of Alcohol & Smoking Patients.
Pregnant women will be excluded. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
TO OBSERVE NADI IN DIFFERENT DEHA PRAKRITI
INDIVIDUALS HAVING DIPTAGNI & MANDAGNI. |
Duration of study- 1.5 years
total- 60 individuals
30 individuals- Mandagni group
30 individuals- Diptagni (Tikshangni) group
Nadi parikshan- manually & by machine(with Nadi Tarangini yantra)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To understand and analyse the relation between nadi, agni & prakriti.
To compile literary data related to Nadi, Agni & Prakriti. |
1.5 YEARS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/05/2023 |
| Date of Study Completion (India) |
05/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
|
Brief Summary
|
A healthy pulse is regular stable and fluctuating and is felt smoothly moving like an earthworm. It neither fast nor slow; neither too strong nor too feeble and the pace is maintained. It is not disturbed and is felt about Angustha moola that is base of thumb on wrist which is sama that is flowing at the same place. There are variants in nadi at different times of day along with variations according to state of health condition and diseased state. There are different Sites of pulse examination like throat, foot, ankle etc. as described in texts. Nadi Parikshan requires expertise who has long experience and skill of reading the pulses for any disease diagnosis. They were popular diagnostic tools in the past but nowadays not specifically used, so there is need to re-establish their results so that they can be used in future. Several problems that remain undiagnosed even with the aid of sophisticated diagnostic tests can be accurately judged by examining the pulse. As there is need to re-establish the usage of this technique in order to get benefitted at the most, there is a need to explore/ investigate the relation of nadi with various physiological factors.
Both Nadi and Agni are markers of health and continuity of life. As aacharyas have mentioned different lakshan of nadi in different states of agni and digestive process. Hence there must be some correlation between the status of Nadi gunas with state of individuals agni (Mandaagni & Tikshnagni). Comparison of lakshanas of nadi in Diptaagni individual and Mandaagni individual i.e., Laghu & Guru; Vegavati & Manda Guna respectively will be done in different Deha Prakriti’s. For this reason, the researcher has selected the topic of study as “AN OBSERVATIONAL STUDY OF NADI IN DIFFERENT DEHA PRAKRITI INDIVIDUALS WITH SPECIAL REFERENCE TO DIPTAGNI & MANDAGNI.†|