| CTRI Number |
CTRI/2023/07/055552 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
22/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation of Day Night with increase and decrease in symptoms of Sandhivata, Amlapitta, and Tmaka shwasa |
|
Scientific Title of Study
|
An observational study to evaluate the correlation of doshik predominance in various stages of day night with kshaya vridhi in lakshanas of sandhivata amlapitta & Tamaka shwasa |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manpreet Gahalawat |
| Designation |
P.G.Scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra |
| Address |
Room no. 71, P.G. Department of Ayurveda Samhita Evum Siddhanta,Shri Krishna Govt. Ayurvedic College and Hospital ,Sector 8 Umri road, Kurukshetrq, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
8053667046 |
| Fax |
|
| Email |
manpreetpreeti157@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Krishan Kumar |
| Designation |
Associate Professor |
| Affiliation |
Shri Krishna Govt. Ayurvedic College and Hospital, kurukshetra |
| Address |
Room no. 72, P.G. Department of Ayurveda Samhita Evum Siddhanta,Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8 Umri road, Kurukshetra , Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9034012752 |
| Fax |
|
| Email |
drkrishanayu08@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Manpreet Gahalawat |
| Designation |
P.G. Scholar |
| Affiliation |
Shri krishna Govt. Ayurvedic College and Hospital, Kurukshetra |
| Address |
Room no. 71, P.G. Department of Ayurveda Samhita Evum Siddhanta, Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8 Umri road, Kurukshetra, Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
8053667046 |
| Fax |
|
| Email |
manpreetpreeti157@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra, Haryana136118 |
|
|
Primary Sponsor
|
| Name |
Shri Krishna Govt Ayurvedic College and Hospital Kurukshetra Haryana |
| Address |
Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8, Umri road , Kurukshetra, Haryana,136118 |
| Type of Sponsor |
Government medical college |
|
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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 Manpreet Gahalawat |
Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra, Haryana |
Room no. 71, P.G. Department of Ayurveda samhita evum Siddhanta, Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8 Umri road, Kurukshetra, Haryana
Kurukshetra
HARYANA |
8053667046
manpreetpreeti157@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shri Krishna Ayush University Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J988||Other specified respiratory disorders. Ayurveda Condition: TAMAKASVASAH, (2) ICD-10 Condition:K318||Other specified diseases of stomach and duodenum. Ayurveda Condition: AMLAPITTAM, (3) ICD-10 Condition:M199||Osteoarthritis, unspecified site. Ayurveda Condition: SANDHIGATAVATAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals between the age group of 20 to 70 years irrespective of the sex having clinical features of Sandhivata, Amlapitta and Tamaka shwasa as described in Ayurvedic Classics were selected.
2. Diagnosis of Sandhivata, Amlapitta and Tamaka shwasa will be purely decided only by considering the sign and symptoms mentioned in classics.
3. In Sandhivata radiology will not be carried out because patients who are already diagnosed radiologically are included in this study |
|
| ExclusionCriteria |
| Details |
1. Patients below 20 years and above 70 years.
2. Patients suffering from other forms of arthritis like RA, Psoriatic arthritis, gout, Ankylosis Spondylitis, infective arthritis and SLE
3. Patients already diagnosed with other systemic diseases such as nephropathic, neuropathic any type of malignant disorder, HTN, DM, Hypo/Hyper thyroidism, Cardiac asthma tropical pulmonary eosinophillia, acute and chronic Bronchitis, bronchiectasis, spontaneous pneumothorax, complicated Bronchial asthma, drug dependent cases and Pregnant women will be excluded from study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relation of Shamana & prakopa of lakshanas of Sandhivata Amlapitta & Tamaka shwasa with respective doshas predominance in different parts of day night in particular patient. |
Approx 1 hour per patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the predominance of doshas in different parts of day & night.
2. To assess the relation of shamana & prakopa lakshanas of sandhivata amlapitta and tamaka shwasa with respective doshas predominance in different parts of day night. |
Approx 1 year & 6 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
03/08/2023 |
| 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
|
Aacharya Vagbhatta has tood the relation of doshas with kala.Different Doshas will be in different awastha kalas during different parts of day night, during stages of life and during different stages of ingestion and digestion of food. In Ayurveda it is said that a general type of disease has the involvement of all the three doshas in different proportions and a specific type of disease is purely caused by a single dosha. Based on predominance of dosha disease are named accordingly as Vataja, pittaja and kaphaja. Like Sandhivata is vata pradhan, Amlapitta is pitta pradhan and Tamaka Shwasa is kapha pradhan vyadhi. This study aims to assess the shamana and prakopa of lakshanas of sandhivata, amlapitta and tamaka shwasa due to predominance of respective doshas in different parts of day night. |