| CTRI Number |
CTRI/2025/01/079463 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic trial for management of Hypothyroidism. |
|
Scientific Title of Study
|
Comparative study to evaluate the efficacy of Ashwagandha Ghrita Nasya and Ashwagandha Kwatha Pana in the management of Hypothyroidism- A Randomized Trial. |
| 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 Vandana Tarkhala |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room No 123, PG Department of Panchakarma, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar
South West
DELHI
110073
India |
| Phone |
7573996759 |
| Fax |
|
| Email |
vandanatarkhala5768@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Arun Gupta |
| Designation |
Head of Department |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room No 142, PG Department of Panchakarma, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, South West Delhi-110073
South West
DELHI
110073
India |
| Phone |
8178361290 |
| Fax |
|
| Email |
arun24@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Arun Gupta |
| Designation |
Head of Department |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room No 142, PG Department of Panchakarma, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, South West Delhi-110073
South West
DELHI
110073
India |
| Phone |
8178361290 |
| Fax |
|
| Email |
arun24@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi,India,Pincode 110073 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar, Najfgarh, New Delhi- 110073 |
| 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 Prof Arun Gupta |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
room no 123, PG Department of Panchakarma, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh
South West
DELHI |
8178361290
arun24@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Chaudhary Brahm Prakash Ayurved Charak Sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Charak samhita Sidhdhi sthan Adhyay 2 Shlok 22, Procedure details: Prepare the patient with Mukhabyanga and Swedana. With Gokarna pot a prescribed quantity of lukewarm Ghrita pour in one side, same procedure should be repeat in other side. Ask the patient to spit the phlegm. It is followed by Kavalgraha and Dhoomapana.)
(1) Medicine Name: Ashwagandha, Reference: Bhaishajya ratnavali Adhyay 71 Shlok 132, Route: Nasal, Dosage Form: Ghrita, Dose: 8(drops), Frequency: od, Duration: 28 Days | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Ashwagandha kwath, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to participate in the study with written and informed consent.
2. Patients with 6-10 IU TSH when peripheral thyroid hormone levels are within normal
reference laboratory range.
3. Patients having clinical features of Hypothyroidism.
4. Either fresh subjects or those pre-diagnosed with Hypothyroidism who are on regular
Thyroxine (up to 25 Mcg).
5. Patients between the ages of 20 to 50yrs. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women.
2. Secondary Hypothyroidism.
3. Patient having any other major complicated disease like Diabetes mellitus, Cardiac
disease, Tuberculosis, AIDS, etc.
4. Patients contraindicated for Nasya Karma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ashwagandha Ghrita Nasya may show a better result than Ashwagandha Kwatha Pana in the
management of Hypothyroidism. |
0th Day, 60th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ashwagandha Ghrita Nasya may or may not show a better result than Ashwagandha Kwatha Pana in the
management of Hypothyroidism. |
0th day, 60th day |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 3 |
|
Date of First Enrollment (India)
|
09/02/2025 |
| 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
|
The study is to compare the effect of Ashwagandha Ghrita Nasya and Ashwagandha Kwatha Pana in the management of the Hypothyroidism. In one group Ashwagandha Ghrita Nasya 8 drpos will be given by nasal root. In another group Ashwagandha Kwatha Pana 40ml orally empty stomach will be given for 60 days. The first assessment will be done at 0th day and the second will be on 60th day in both groups. The trial will conduct in Ch. Brahm Prakash Ayurved Charak Sansthan with outcome Ashwagandha Ghrita Nasya may show better effect than Ashwagandha Kwatha Pana in the management of the Hypothyroidism. |