| CTRI Number |
CTRI/2025/05/086946 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use Of Ashwagandha Choorna and Thyroxine Sodium Tablet in Management Of Hypothyroidism. |
|
Scientific Title of Study
|
Randomized Clinical Controlled Assessment of Ashwagandhadi Choorna in comparison to Thyroxine Sodium Tablet in the Management of Galganda (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 Nandita Rajesh Arora |
| Designation |
PG Scholar |
| Affiliation |
Dr. G.D.Pol Foundation YMT Ayurvedic medical college Kharghar |
| Address |
OPD No.8 Kayachikitsa Dept. Dr.G.D.Pol Foundation YMT Ayurvedic Medical College And Hospital,Institutional Area sector 4 Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8219590072 |
| Fax |
|
| Email |
aroranandita500@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh H Pandey |
| Designation |
Associate Professor |
| Affiliation |
Dr. G.D.Pol Foundation YMT Ayurvedic medical college Kharghar |
| Address |
OPD No.8 Kayachikitsa Dept Dr.G.D.Pol Foundation YMT Ayurvedic Medical College And Hospital,Institutional Area sector 4 Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9820006082 |
| Fax |
|
| Email |
drpandeymahesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandita Rajesh Arora |
| Designation |
PG Scholar |
| Affiliation |
Dr. G.D.Pol Foundation YMT Ayurvedic medical college Kharghar |
| Address |
OPD No.8 Kayachikitsa Dept. Dr.G.D.Pol Foundation YMT Ayurvedic Medical College And Hospital,Institutional Area sector 4 Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8219590072 |
| Fax |
|
| Email |
aroranandita500@gmail.com |
|
|
Source of Monetary or Material Support
|
| G.D.Pol foundation YMT Ayurvedic medical college and hospital sector 4 Kharghar Navi Mumbai 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Nandita Rajesh Arora |
| Address |
OPD NO.8 Kayachikitsa dept. Dr.G.D.Pol Foundation YMT Ayurvedic Medical College And Hospital,Institutional Area Sector 4 Kharghar Navi Mumbai 410210. Maharashtra India |
| Type of Sponsor |
Other [SELF] |
|
|
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 Nandita Rajesh Arora |
YMT Ayurvedic Medical College |
OPD No.8 Kayachikitsa Department,DR.G.D.Pol Foundation,YMT Ayurvedic Medical College Sector 4 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA |
8219590072
aroranandita500@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandhadi churn, Reference: Sahasrayog, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Thyroxine Sodium | As per requirement 1.5microgram/kg/body weight (Dose)
Once a day (Frequency)
Route of administration - Oral
Time of administration- Early morning Empty stomach
Duration - 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Serum Ultrasensitive level 15-20 micro IU/ML
2.Newly diagnosed cases of hypothyroidism less than Six months ago.
3.Subject having one or more classical symptoms.
4.Patient of either gender.
5.Age 18 years and 40 years |
|
| ExclusionCriteria |
| Details |
1.Immunocompromised patients or patients on immunosuppressive drugs.
2.Patients suffering from life threatening diseases.
3.Pregnancy and lactating mother.
4.K/C/O Thyroid Neoplasia.
5.Progressive cases of Myxedema coma.
6.Patients of Subclinical Hypothyroidism |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the symptomatic relief.
2. To observe the changes in TSH level. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the Probable mode of action of Ashwagandhadi Churna in
management of Hypothyroidism. |
3 moths |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
30/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/05/2025 |
| 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 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 current study aimed as Randomized Clinical Controlled Assessment Of Ashwagandhadi Choorna In Comparison To Thyroxine Sodium Tablet In The Management Of Galganda (Hypothyroidism). The symptoms of Hypothyroidism are Weight gain, Loss of appetite , Oligomenorrhoea, Dryness of skin, Loss of hairs, Dyspnoea etc. Ashwagandhadi choorna 12gm (one karsha ) is given in the morning empty stomach as experimental group medicine in two divided doses. It will be given for 3 months. Tab Thyroxine sodium is used as control group medicine for 3 months. Assessment for both will be done at 0th day, 45th Day 90th day. Assessment done on the basis of subjective criteria and Objective criterias. Clinical assessment is done after every 45th day.
Hypothyroidism is one of the most common Thyroid disorders in India affecting one in 10 adults. In ayurveda parlance, this is attributed as the function of Agni (system related to metabolism ).In modern science, the treatment of Hypothyroidism is done by Thyroxine Harmone therapy for long time but this medication Ashwagandhadi Choorna has Deepan , Pachan quality which pops by metabolism and also have Thyroid stimulatory properties.
The Content of Ashwagandhadi Choorna is easily available and cost effective in nature hence selected for the present study. |