| CTRI Number |
CTRI/2024/05/067233 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of Vamanakarma followed by shunthi churna in one group of 15 patients and only shunthi churna without Vamanakarma in other group of 15 patients of hypothyroidism wsr to Agnimandya. |
|
Scientific Title of Study
|
A Comparative study on the efficacy of Shunthi Churna with and without Vamana Karma in the management of Hypothyroidism wsr to Agnimandya. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Kumari |
| Designation |
MD Scholar(Ayu.) |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Department of Panchakarma Government Ayurvedic College and Hospital,
Landmark-Buddha Murti
Kadamkuan, Patna
Department of Panchakarma, Kadamkuan, Patna-800003
Landmark-Buddha Murti
Patna
BIHAR
800003
India |
| Phone |
7294070143 |
| Fax |
- |
| Email |
nidhikr0303@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Akhilesh Prasad Singh |
| Designation |
HOD & Associate Professor Department of Panchakarma |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Department of Panchakarma,
Government Ayurvedic College and Hospital, Patna
Department of Panchakarma, Kadamkuan, Patna-800003
Landmark-Buddha Murti
Patna
BIHAR
800003
India |
| Phone |
8002680973 |
| Fax |
- |
| Email |
drapsinghpatna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Akhilesh Prasad Singh |
| Designation |
HOD &Associate Professor, Department of Panchakarma |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Department of Panchakarma,
Government Ayurvedic College and Hospital,Kadamkuan near Buddha murti, Patna
Department of Panchakarma Kadamkuan, Patna-800003
Landmark-Buddha Murti
Patna
BIHAR
800003
India |
| Phone |
8002680973 |
| Fax |
- |
| Email |
drapsinghpatna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Kadamkuan, Patna-800003,Bihar, India |
|
|
Primary Sponsor
|
| Name |
Nidhi Kumari |
| Address |
Department of Panchakarma,
Government Ayurvedic College and Hospital, Kadamkuan, Patna-800003, Bihar, 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 Nidhi Kumari |
Government Ayurvedic College and Hospital |
Department of Panchakarma,
OPD No.11, Kadamkuan near Buddha murti, Patna-800003
Patna
BIHAR |
7294070143
-
nidhikr0303@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(IEC of Government Ayurvedic College and Hospital, Patna-800003,Bihar) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: AGNIVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: agnivardhaka yoga, Reference: chakradatta chikitsa sangrah,english translation by Dr. G Prabhakar Rao, chapter 6 Agnimaandyaadi chikitsa, shlok 3, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Comparator Arm | Procedure | - | Vamana Karma | (Procedure Reference: Charak samhita sutra sthana ,chapter 16, shloka 17, Procedure details: Deepana-Pachana for 3-5days
Abhyantara snehpana for 3-5days as per requirement
Next day kaphotkleshak aahar along with Sarvanga abhyanga & Sarvanga vaspa swedana for 1 day
Next morning Sarvanga abhyanga & Sarvanga vaspa swedana followed by yavagu sevana which again is followed by administration of Vaamak aushadha (given with mantrochharana). After Samyak Vamana will take place, patients will be advised to do Kavala followed by Vairechanik Dhoompana.
From same day evening patients will be p)
(1) Medicine Name: Shunthi churna , Reference: Agnivardhaka yoga, Chakrapanidatta chikitsa sangrah, Agnimaandyadi chikitsa chapter 6, shloka 3, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Vamana yogya
2.person between the age group of 20-60 years
3.diagnosed cases of Hypothyroidism (primary and subclinical)on the basis of Sr. TSH, Sr. T3,Sr. T4
4.patients with clinical sign and symptoms of hypothyroidism |
|
| ExclusionCriteria |
| Details |
1.Vamana Ayogya
2.Patients with HTN, Asthma, Cardiac disease, diabetes, pregnancy and other systemic disorders which may lead the patient to fatal condition during the VamanaKarma
3.Patients with congenital and Secondary Hypothyroidism
4.If Serum TSH level more than 100mIU/L were excluded
5.chronicity of hypothyroidism more than
5years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sign and symptoms will be assessed before and after treatment . Those are puffiness over face and eyelids, oedema, dry and coarse skin,breathlessness, constipation, weakness,lethargy,fatigue,muscle ache,duration of menstrual blood, interval between two menstrual cycles and hairfall |
Group A 45 days
Group B 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Thyroid profile test investigations will be done in patients before and after treatment. Increased Serum TSH level is the key marker of hypothyroidism and changes in its level is to be assessed |
Group A 45 days
Group B 28 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 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| 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="8"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nidhikr0303@gmail.com].
- For how long will this data be available start date provided 25-04-2025 and end date provided 25-04-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized,open,interventional prospective trial comparing the effectiveness of shodhan purvak shamana chikitsa[ Vamana followed by shunthi churna] and shamana chikitsa[ shunthi churna] in the management of hypothyroidism wsr to Agnimaandya. this study will be conducted in Government Ayurvedic College and Hospital, Patna, Bihar in the Department of Panchakarma. Patients will be treated within 2 groups. GROUP A- 15 patients will be treated with Vamana karma then shunthi churna will be administered to them for 28 days BD with lukewarm water on empty stomach . Prior to Vamana karma patients will undergo through purvakarma i.e. deepana pachana with trikatu, snehapana, abhyanga and swedana. GROUP B- In 15 patients shunthi churna will be administered for 28 days BD with lukewarm water on empty stomach. in both the groups patients are advised to visit the hospital post intervention ,once a week i.e. weekly for 4 weeks. |