| CTRI Number |
CTRI/2024/07/069901 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate the effect of Shakotaka Taila nasal drops with Krimighnadi Kashaya and Phalatrikadi Kashaya orally in the management of Primary Hypothyroidism with Obesity |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate the effect of Shakotaka Taila Pratimarsha Nasya with Krimighnadi Kashaya and Phalatrikadi Kashaya in the management of Primary Hypothyroidism with Obesity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shruthi Shivarama |
| Designation |
Assistant Professor Kayachikitsa |
| Affiliation |
SDM Institute of Ayurveda and Hospital Bengaluru |
| Address |
OPD 27 Kayachikitsa
SDM Institute of Ayurveda and Hospital
SH17 Anchepalya Challegatta Bengaluru Karnataka
OPD 10 Kayachikitsa
Government Ayurveda Medical college PG AND PhD Research Center Sayyaji Rao Road, Mysore 570001
Bangalore
KARNATAKA
560074
India |
| Phone |
9483878863 |
| Fax |
|
| Email |
shivarama.shruthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mythrey R C |
| Designation |
Pofessor and HOD |
| Affiliation |
Rajiv GAndhi University and Health Sciences Bengaluru |
| Address |
OPD 10 Kayachikitsa
Government Ayurveda medical college PG AND PhD research center Sayyaji rao road Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
86168570803 |
| Fax |
|
| Email |
mythreyrc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mythrey R C |
| Designation |
Pofessor and HOD |
| Affiliation |
Rajiv GAndhi University and Health Sciences Bengaluru |
| Address |
OPD 10 Kayachikitsa
Government Ayurveda medical college PG AND PhD research center Sayyaji rao road Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
86168570803 |
| Fax |
|
| Email |
mythreyrc@gmail.com |
|
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Source of Monetary or Material Support
|
| Government Ayurveda medical college PG AND PhD research center Sayyaji rao road Mysore Karnataka 570001
|
| SDM Institute of Ayurveda and Hospital
SH17 Anchepalya Challegatta Bengaluru Karnataka 560074 |
|
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Primary Sponsor
|
| Name |
Dr Shruthi Shivarama |
| Address |
SDM Institute of Ayurveda and Hospital
SH17 Anchepalya Challegatta Bengaluru Karnataka 560074 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shruthi Shivarama |
Government Ayurveda medical college |
OPD 10 Kayachikitsa
Government Ayurveda medical college PG AND PhD research center Sayyaji rao road Mysore 570001
Mysore
KARNATAKA |
9483878863
shivarama.shruthi@gmail.com |
| Dr Shruthi Shivarama |
SDM Institute of Ayurveda and Hospital |
OPD 27 Kayachikitsa
SDM Institute of Ayurveda and Hospital
SH17 Anchepalya Challegatta Bengaluru Karnataka 560074
Bangalore
KARNATAKA |
9483878863
shivarama.shruthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| GOVERNMENT AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
Approved |
| SRI DHARMASTHALA MANJUNATHESHWARA INSTITUTE OF AYURVEDA AND HOSPITAL |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: RASAVAHASROTOVIKARAH, (2) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: RASAVAHASROTOVIKARAH, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Phalatrikadi Kashaya, Reference: Kaviraj Ambikadatta shastri Ayurvedacharya; Bhaishajya Ratnavali, edited and enlarged by Shri Bramhashankar Mishra, Editor Shri Rajeshwaradatta Shastri, Prameha Chikitsa Prakarana Ch-37, Ver. 17; reprinted 2017 Varnasi: Chaukambha Prakashan; p.721., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: jala), Additional Information: - | | 2 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: Ashtanga Hridaya sutrasthana 20/26, Procedure details: 2 times/ day before food)
(1) Medicine Name: Shakotaka Taila, Reference: Acharya Govindadas Sen, Bhaishajya Ratnavali Siddhi Prada, Galaganda Gandamala Apachi Chikitsa Prakarana, Translated by Siddinandana Mishra, Varnasi: Chaukambha Surabharati Prakasha, 2017, 44/76; p.831, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 60 Days | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Krimighnadi kashaya, Reference: K. Nishteshwar, R. Vidyanath; Sahasrayoga, Parishishta Prakarana Ch-10, Ver. 104; 2017 Varnasi: Chaukambha Sanskrit Series Office; p. 401, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fulfilling the diagnostic criteria.
Both fresh and treated cases of hypothyroidism will be included.
Freshly detected and untreated cases of hypothyroidism.
Established and treated cases of hypothyroidism also who are ready to discontinue the earlier medication with Flush out period of 15 days.
Patients with hypothyroidism BMI more than 25.
Subjects with serum TSH more than 5 to less than 10 ml IU/L and more than 10ml Primary Hypothyroidis with decrease fT4 and fT3.
Who signed the informed consent.
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| ExclusionCriteria |
| Details |
Subjects with congenital hypothyroidism, chronic history of hypothyroidism more than 5 yrs and secondary hypothyroidism or tertiary hypothyroidism.
subjects with any chronic systemic disorders like cerebrovascular accidents, ischemic heart diseases, uncontrolled diabetes mellitus, uncontrolled hypertension, any active malignancies, chronic renal failure, radiation therapy etc which interrupt the present intervention.
Subjects who have undergone thyroid surgery.
Pregnant and lactating women.
Diagnosed cases of neoplastic conditions, toxic goiter, drug induced hypothyroidism will also be excluded.
Who doesn’t sign the informed consent.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pratimarsha nasya with Shakotaka Taila and Krimighnadi Kashaya efficacy in treating primary hypothyroidism with obesity
assessing improvement with with diagnostic criteria-
Thyroid profile (Serum)TSH, fT3, fT4 and TPO-ab.
Waist circumference
waist hip ratio
Subjective criteria-
Clinical signs and symptoms
Zulewski’s clinical score for hypothyroidism.
|
1st Initial Assessment- 0th day
2nd Assessment - 30th day
3rd Assessment - 61st day
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Establishing a safe, effective, non levothyroxine hormone supplement dependent formulation in the management of Hypothyroidism with Obesity.
2. Establishing whether intervention is improving the quality of life of Hypothyroidism with Obesity
|
1st Initial Assessment- 0th day
2nd Assessment - 30th day
3rd Assessment - 61st day
|
|
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Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="3"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The aim of this clinical study is to compare the effects of Krimighnadi kashaya and Phalatrikadi kashaya as an oral medication and Shakotaka Taila as Pratimarsha nasya in te management of primary hypothyroidisim with obesity. 140 subjects satisfying diagnostic and inclusion criteria will be divided into 2 groups of 70 subjects each. Intervention will be given for 8 weeks. Post 8 weeks of intervention, the subjects will be assessed for changes in regards to subjective, diagnostic criteria, assessment criteria scales assessed. Formulating safe, effective, non drug dependent formulation in management of primary hypothyroidism with obesity. Improving quality of life in present condition.
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