| CTRI Number |
CTRI/2024/12/078782 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Hypothyroidism in ayurvedic perspective |
|
Scientific Title of Study
|
The probability of Hypothyroidism in Ayurveda - A Clinico -
Pathological Study |
| 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 DEEPIKA PATIAL |
| Designation |
PG SCHOLAR ROGA NIDAN EVUM VIKRITI VIGYAN DEPARTMENT |
| Affiliation |
Pt. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT NEHRU NAGAR KOLAR BYPASS ROAD BHOPAL MADHYA PRADESH 462003 INDIA
SCIENCE HILLS BEHIND MANI NEHRU NAGAR KOLAR BYPASS ROAD BHOPAL MADHYA PRADESH 462003 INDIA
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9610526090 |
| Fax |
|
| Email |
dppatyal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJAY SRIVASTAVA |
| Designation |
PROFESSOR AND HOD OF ROGA NIDAN EVUM VIKRITI VIGYAN DEPARTMENT |
| Affiliation |
Pt KHUSHILAL SHARMA GOVT (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT NEHRU NAGAR KOLAR BYPASS ROAD BHOPAL MADHYA PRADESH 462003 INDIA
SCIENCE HILLS BEHIND MANIT NEHRU NAGAR KOLAR BYPASS ROAD BHOPAL MADHYA PRADESH 462003 INDIA
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425012608 |
| Fax |
|
| Email |
sanjayayurvedabhopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEEPIKA PATIAL |
| Designation |
PG SCHOLAR OF ROG NIDAN EVUM VIKRITI VIGYAN DEPARTMENT |
| Affiliation |
Pt Khushilal Sharma Govt (Auto) Ayurveda College and Institute Bhopal |
| Address |
SCIENCE HILLS BEHIND MANIT NEHRU NAGAR KOLAR BYPASS ROAD BHOPAL MEDHYA PRADESH 462003 INDIA
SCIENCE HILLS BEHIND MANIT NEHRU NAGAR KOLAR BYPASS ROAD BHOPAL MEDHYA PRADESH 462003 INDIA
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9610526090 |
| Fax |
|
| Email |
dppatyal@gmail.com |
|
|
Source of Monetary or Material Support
|
| PT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Govt Auto Ayurveda College Institute Bhopal |
| Address |
Science Hills Behind Manit Kolar Nehru Nagar Bypass Road Bhopal Madhya Pradesh 462003 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deepika Patial |
Pt Khushilal Sharma Govt.(Auto) Ayurveda College And Institute Bhopal |
Rog Nidan Evum Vikriti
Vigyan Department
Room No 6 Ground
floor Science Hills
Behind Manit , Kolar
Nehru Nagar Bypass
Road ,Bhopal Madhya
Pradesh 462003 India
Bhopal
Madhya pradesh
Bhopal
MADHYA PRADESH |
9610526090
dppatyal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Pt Khushilal Sharma Government college and institute bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants between the age group of 21 to 60 years of either sex and
irrespective of their religion and occupation.
2. Known case of hypothyroidism.
3. Participants willing to sign informed written consent forms for participation in
the research study. |
|
| ExclusionCriteria |
| Details |
1. Participants not fulfilling the inclusion criteria.
2. Participants have a history of disease like Cardiovascular disease, Malignancy,
Tuberculosis, Diabetes Mellitus, Renal Function impairment, Hypertension,
RHO etc.
3. Pregnant women and Lactating mothers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| RELATIONSHIP BETWEEN PANDUROGA AND HYPOTHYROIDISM CAUSES AND CLINICAL FEATURES |
RELATIONSHIP BETWEEN CAUSATIVE FACTOR AND CLINICAL FEATURES OF PANDUROGA AND HYPOTHYROIDISM |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is further expected that this study will be helpful in clinical practice for the management of Hypothyroidism. |
12 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/01/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
CRITERIA FOR DIAGNOSIS: Individual having more than 06 sign and symptoms of subjective parameters will be selected considering the identical features between Pandu Roga and Hypothyroidism as detailed below: • Daurbalya, Aarohanaayas (Tiredness, weakness) • Ruksha, Swedabhav (Dry skin) • Shishirdveshi (Cold intolerance) • Katiurupadasadan (Paraesthesia) • Gatrashool, Pidiko-udeshtan, Mraditriv (Muscle cramps) • Shoonakshikoot (Peri orbital oedema/ Puffy face) • Kopan (Mood alteration/ irritability) • Bhrama (Impairment of concentration) • Sheemaloma (Hair loss/diminished body hairs) • Hatanal, Aruchi (Poor appetite) • Swasa (Dyspnea) • Pandura (Pallor) • Alpavaka (Diminished voice/Hoarse) • Alapraktata (Amenorrhoea/Oligomenorrhoea)
INVESTIGATION: • Complete Blood Count (CBC) • Serum ferritin
CRITERIA FOR THE SELECTION OF PATIENT:
INCLUSION CRITERIA: 1. Participants between the age group of 21 to 60 years of either sex and irrespective of their religion and occupation. 2. Known case of hypothyroidism. 3. Participants willing to sign informed written consent forms for participation in the research study.
EXCLUSION CRITERIA: 1. Participants not fulfilling the inclusion criteria. 2. Participants have a history of disease like Cardiovascular disease, Malignancy, Tuberculosis, Diabetes mellitus, Renal Function impairment, Hypertension, RHO etc. 3. Pregnant women and Lactating mothers. |