| CTRI Number |
CTRI/2022/04/041744 [Registered on: 08/04/2022] Trial Registered Prospectively |
| Last Modified On: |
03/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Ayurveda |
| Study Design |
Other |
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Public Title of Study
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Effect of Laghu-vaishvanar Churna and Dhanya Nagar kwath in management of Sublinical Hypothyroidism |
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Scientific Title of Study
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A Randomized Comparative Clinical Study To Evaluate The Efficacy of Laghuvaishvanarchurna And *Dhanyanagarkwath In The Management Of Dhatvagnimandhya wsr To Subclinical Hypothyroidism |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ish Garg |
| Designation |
MD SCHOLAR, PG Department of Kayachikitsa |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Room no. 6, Adamji Block, Department of Kayachikitsa, A and U Tibbia College & Hospital ,Karol Bagh, Delhi
Central
DELHI
110005
India |
| Phone |
9958119258 |
| Fax |
|
| Email |
ishgarg4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Yadav |
| Designation |
H.O.D. and Associate Professor, PG Department of Kayachikitsa |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Room no. 6, Adamji Block, Department of Kayachikitsa, A and U Tibbia College & Hospital ,Karol Bagh, Delhi
Central
DELHI
110005
India |
| Phone |
9354925030 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Yadav |
| Designation |
H.O.D. and Associate Professor, PG Department of Kayachikitsa |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Room no. 6, Adamji Block, Department of Kayachikitsa, A and U Tibbia College & Hospital ,Karol Bagh, Delhi
Central
DELHI
110005
India |
| Phone |
9354925030 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College Hospital |
|
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Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College Hospital |
| Address |
Ayurvedic and Unani Tibbia College & Hospital ,Karol Bagh, Delhi-110005 |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ish Garg |
Ayurvedic and Unani Tibbia College and Hospital |
Room 6, PG department of Kayachikisa, Ayurvedic and Unani Tibbia College and Hospital ,Karol Bagh, Delhi-110005
Central
DELHI |
9958119258
ishgarg4@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Ayurvedic and Unani Tibbia College |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: SITAGNITAÂ (AGNIMANDYAM)Â (KEVALA-KAPHA), |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Laghu Vaishvanar churna, Reference: Yog Ratnakara- edited by Bhisagratna Brahmasankar Sastri, 2nd edition, 1973, ajirna chikitsa vyakhya, yoga 1, page no. 317, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Lukewarm water ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhanya Nagar kwath, Reference: Yog Ratnakara- edited by Bhisagratna Brahmasankar Sastri, 2nd edition, 1973, ajirna chikitsa vyakhya, yoga 1, page no. 322, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 35(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Laghu Vaishvanar churna, Reference: Yog Ratnakara- edited by Bhisagratna Brahmasankar Sastri, 2nd edition, 1973, ajirna chikitsa vyakhya, yoga 1, page no. 317, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Lukewarm water ), Additional Information: -(2) Medicine Name: Dhanya nagar kwath, Reference: Yog Ratnakara- edited by Bhisagratna Brahmasankar Sastri, 2nd edition, 1973, ajirna chikitsa vyakhya, yoga 1, page no. 322, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 35(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: - |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to participate in the trial and sign the consent form.
2. The patients between the age group of 18 to 60 years in either sex.
3. Patients of subclinical hypothyroidism with features mentioned in subjective parameters.
4. On the basis of raised serum TSH(5-10 μIU/ml) and normal serum T4 level. |
|
| ExclusionCriteria |
| Details |
1. Patients who were not willing for trial.
2. TSH level more than 10 or less than 5 μIU/ml.
3. Patient with presenting sign of moderate to severe or unmanageable bradycardia (<50bpm)
4. Patients who are suffering from hypothyroidism for more than 10 year.
5. Patients suffering from any other systemic illness Diabetes, HTN, liver disorder, tuberculosis etc.
6. Pregnant and lactating patients.
7. Patients taking antibiotic therapy for any systemic illness within 2 months.
8. H/O of hypersensitivity of any trial drug.
9. Patient who fail to give consent.
10. Patients with genetic disorder, chronic disorder like paralysis, cancer, renal failure, hepatic failure and
IHD. |
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Alternation |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
Improvement in Subjective parameters
1. Weakness (Grade 0-3)
2. Dry skin (Grade 0-3)
3. Feeling cold (Grade 0-3)
4. Constipation (Grade 0-3)
5. Poor apetite (Grade 0-3)
6. Dyspnea (Grade 0-3)
7. Hoarse voice (Grade 0-3)
8. Menorrhagia (Grade 0-3)
9. Paraesthesia (Grade 0-3)
10. Weight gain (Grade 0-3) |
At baseline and at 3 months |
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Secondary Outcome
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| Outcome |
TimePoints |
| Changes in Thyroid Profile i.e. T3, T4, TSH values |
At baseline and at 3 months |
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 2/ Phase 3 |
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Date of First Enrollment (India)
|
20/04/2022 |
| 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="3"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Nil |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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INTRODUCTION Hypothyroidism is a very common disease in human beings. It is a clinical syndrome due to deficiency of thyroid hormones, which result in a generalized slowing down of metabolic process. Hypothyroidism is one of the major disease of thyroid gland involving most of the system of the body. Subclinical hypothyroidism is defined as mildly reduced function of thyroid gland with either minimal symptoms or no symptoms of hypothyroidism having an elevated serum TSH (Thyroid stimulating hormone) level and normal concentration of free T3(Triiodothyronine)FT3, free T4(Thyroxine)FT4, T3 and T4. Although this definition is based on biochemical criteria. It is well recognized that some individual patients may present with symptoms and sign of hypothyroidism. It is confirmed by laboratory diagnosis of serum levels of elevated TSH and normal FT4 and T3. Antithyroid antibodies can be detected in 80% of patient with subclinical hypothyroidism. Positive thyroid antibody titers suggest autoimmune thyroid disease. Euthyroid patient with positive thyroid peroxidase antibody (TPO) titers have high chance of developing hypothyroidism. It is usually primary disease of thyroid but may be secondary due to disturbances of hypothalamic-pituitary axis. In Ayurveda, there is no exact mentioned of the disease but it could be correlated with Kaphaja Shotha, Kaphaja Galganda and Rasaja Pradoshaja vikar described by the Acharya. In the Charak Samhita eight type of nindita purusha have been described which can be taken as functional disorders of endocrine. As per the concept of Agni, normalcy of Agni is must for body function rhythmicity. In Ayurveda texts it is mentioned that metabolic process is controlled by Jatharagni, Bhutagni, Dhatvagni. So, the cause of disease is alteration in metabolic activity which according to Ayurveda, is vitiation of Dhatvagni. Agnimandhya at any level due to kaphakara nidan results increased dhatugat mala sanchay, resulting in srotorodh causing compromised dhatu saras, leading to both physical and mental features in subclinical hypothyroidism. LITERATURE REVIEW - In Ayurveda there is no direct mention of hypothyroidism. But on the basis of its clinical presentation, it can be correlated with different entities which one explained either as symptoms or disease. So it’s difficult to give a single Ayurvedic term for it. There are many systems which involves in the pathogenesis of hypothyroidism. On the basis of Ayurvedic principles we can understand the pathology of hypothyroidism. We find that it is basically caused due to dysfunctioning of the Jatharagni (Agnimandhya), which is further leads to Bhutagni and Dhatvagni vitiation, ultimately causing pathological condition of hypothyroidism. This agnimandhya results in formation of abnormal Ras dhatu i.e. Aama lakshna and the symptoms seen in subclinical hypothyroidism are similar. DRUGS REVIEW: LAGHU VAISHVANAR CHURNA - The classical preparation is mentioned in Yog Ratnakar. Its content drugs Saindhav lavan, Haritaki, Pippali, Chitrak mool. DHANYA-NAGAR KWATH -The classical preparation is mentioned in Yog Ratnakar. Its content drugs Shunthi, Dhanya. Routine Investigations : Investigations will be done before starting the therapy and at completion of trial. Assessment of the therapy will be done by evaluating their value before and after completion of trial. ▪ Haematological investigation- CBC ESR Blood sugar-F and PP, ▪ Biochemical investigation- LFT, KFT, Urine - routine & microscopy, Other investigation like ECG, Chest x- ray, USG, CT-scan, MRI, TMT, would be done if necessary. • • • • • • • 14
Specific Investigations : 1. T3 (Tri-iodothyronine) 2. T4 (Thyroxine) 3. TSH (Thyroid-stimulating hormone) 4. Anti-TPO (Thyroid peroxidase antibody) PARAMETERS FOR ASSESSMENT OF STUDY OUTCOMES PRIMARY END POINT Improvement in subjective symptoms. SECONDARY END POINT Change in Thyroid profile before and after the study
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