| CTRI Number |
CTRI/2024/06/068696 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of dhatwagnimandya (Hypothyroidism)i.e. high TSH, weakness, hairloss, weight gain |
|
Scientific Title of Study
|
An Exploratory single arm study on the efficacy of Moorvadi Agad in Garavisha janya dhatwagnimandya (Hypothyroidism) |
| 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 Neelanjana Sen |
| Designation |
PG Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Jodhpur Rajasthan |
| Address |
PG Department of Agad Tantra Post Graduate Institute of Ayurved
Dr Sarvepalli Radhakrishnan Rajasthan ayurved university
jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8114400551 |
| Fax |
|
| Email |
neelanjana117@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelanjana Sen |
| Designation |
PG Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Jodhpur Rajasthan |
| Address |
PG Department of Agad Tantra Post Graduate Institute of Ayurved
Dr Sarvepalli Radhakrishnan Rajasthan ayurved university
jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8114400551 |
| Fax |
|
| Email |
neelanjana117@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritu Kapoor |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Ayurved Jodhpur Rajasthan |
| Address |
PG Department of Agad Tantra Post Graduate Institute of Ayurved
Dr Sarvepalli Radhakrishnan Rajasthan ayurved university
jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7976967729 |
| Fax |
|
| Email |
drritukapoor4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Jodhpur Rajasthan |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Jodhpur 342037 |
| Address |
PG Department of Agad Tantra Post Graduate Institute of Ayurved
jodhpur 342037 |
| 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 Neelanjana Sen |
Sanjeevani Hospital Post Graduate Institute of Ayurved Jodhpur |
PG department of Agad
tantra Post graduate
institute of ayurved
jodhpur
Jodhpur
RAJASTHAN |
8114400551
neelanjana117@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Post Graduate Institute of Ayurved Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: GARAVISHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Moorvadi Agad, Reference: Ashtang Sangrah Uttar Sthan Chapter 40 Shloka 88, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Luke warm water or Takra or Dadhi mastu ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between the age of 18-60 years of either sex.
2. Patient having history of consuming gara visha (as per mentioned in questionnaire) for a
long period of time.
3. Patient having TSH level more than 5.4 µlt/ml and less than 15 µlt/ml will be taken.
4. Patients having sign and symptoms of Primary Hypothyroidism.
5. Patients who are already diagnosed as hypothyroidism and are under medication but
still presenting with the increased TSH level.
6. Patient willing to give consent for clinical trial of either sex. |
|
| ExclusionCriteria |
| Details |
1.Patients below 18 years and above 60 years of age.
2.TSH level below 5.5 µlt/ml & TSH level above 14µlt/ml.
3.Patients suffering from congenital hypothyroidism and secondary hypothyroidism.
4.Pregnant women, Lactating mother are excluded.
5.Patient diagnosed with hyperthyroidism, neoplasia, toxic goiter are excluded
6. Patients who have under gone any type of thyroid surgery.
7. Mentally ill/ Retarded patients.
8. Patients having diabetes mellitus and any systemic disorders or any congenital
disorders are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in TSH level of the patient. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Reduction in body weight, BMI
2.Changes in the general symptoms of hypothyroidism like general weakness, tiredness, hairloss,constipation, menstrual abnormality
3.Changes in the general symptoms of concocted Poison
|
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/07/2024 |
| 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="0"
Months="9"
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
|
Type of study : Interventional Purpose : Treatment/ Efficacy. Timing : Prospective End point : Effectiveness Duration : 60 days Sample size : 30 Patient Criteria for selection : Clinically diagnosed and registered patients of Hypothyroidism with gara visha history attending the OPD of Dr. Sarvepalli Radhakrishnan Ayurveda University, Jodhpur, and from
other government hospitals of Jodhpur will be taken. Posology Drug- Moorvadi Agad Kalpana- Choorna Dose- 3 gm Route of administration- Oral Time of administration -Thrice a day (Before Meal) Anupana- Luke warm water or Takra or Dadhi mastu Duration- 60 days Follow up 1.Duration of clinical study will be 60 days. 2.All patients will be followed up once in 15th day regularly. 3. Improvements and other effects will be noted. 4. Clinical assessment will be done once in 15th day. 5.Pathya ahara and vihara will be noted during follow up |