| CTRI Number |
CTRI/2024/12/077600 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Dhatvagnimandya Vikrati(Hypothyroidism)Through Ayurveda |
|
Scientific Title of Study
|
An Exploratory Study to Evalauate the Combined Efficasy of Sinduthaadi Modaka and Nasya of Katutumbi Taila in the Management of Dhatvagnimandya Vikrati (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 GUDDI |
| Designation |
PG SCHOLAR |
| Affiliation |
post graduate institute of ayurved, jodhpur |
| Address |
P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur RAJASTHAN 342037 India
RAJASTHAN
342037
India P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur
RAJASTHAN
342037
India Jodhpur RAJASTHAN 342037 India |
| Phone |
6376134174 |
| Fax |
|
| Email |
guddipanwar6376@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR BRAHMANAND SHARMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
post graduate institute of ayurved, jodhpur |
| Address |
ROOM NO 118 PG DEPARTMENT OF KAYACHIKITSA POST GRADUATE INSTITUTE OF AYURVED DR S R RAJASTHAN AYURVED UNIVERSITY
JODHPUR
RAJASTHAN
342037
India
Jodhpur RAJASTHAN 342037 India |
| Phone |
9460318138 |
| Fax |
|
| Email |
bkmudgal9@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR GUDDI |
| Designation |
PG SCHOLAR |
| Affiliation |
post graduate institute of ayurved, jodhpur |
| Address |
P.G. Department of Kayachikitsa, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
Jodhpur RAJASTHAN 342037 India |
| Phone |
6376134174 |
| Fax |
|
| Email |
guddipanwar6376@gmail.com |
|
|
Source of Monetary or Material Support
|
| post graduate institute of ayurved jodhpur Rajasthan India 342037 |
|
|
Primary Sponsor
|
| Name |
post graduate institute of ayurved jodhpur |
| Address |
P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur
RAJASTHAN
342037
India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR GUDDI |
P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Jodhpur
RAJASTHAN
342037
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR GUDDI |
post graduate institute of ayurved jodhpur |
P.G. Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Jodhpur
RAJASTHAN
342037
India Jodhpur RAJASTHAN |
6376134174
guddipanwar6376@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE POST GRADUATE INSTITUTE OF AYURVED JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: MANDAGNIH/Â AGNISADA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sindhuthaadi Modaka, Reference: Chakrdatta, Route: Oral, Dosage Form: Modaka , Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing for the trial.
Patients between the age of 18-60 years of either sex.
Patients who are newly diagnosed of Hypothyroidism with increased TSH levels.
Subjects coming with chief complain of unexplained weight gain cold intolerance constipation
hoarseness of voice fatigue depression edema.
Subjects detected with TSH between 5-20 Miu/L |
|
| ExclusionCriteria |
| Details |
Patients below the age of 18 years and above 60 years.
Patients suffering from congenital hypothyroidism and secondary hypothyroidism hypertension.
Subject having multi neoplasm toxic goiter is excluded.
Patients who have undergone any type of thyroid surgery.
Pregnant and lactating women are excluded.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assessment Of Subjective And Objective Parameters Before And After Treatment |
90 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe any side effects if occur during
clinical trial |
90 DAYS |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
13/12/2024 |
| 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="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
|
INTRODUCTION Hypothyroidism is the most common endocrinal disorder that occurs when the thyroid gland does not
make enough thyroid hormone to meet the body’s needs. Thyroid gland produces two hormones Thyroxine
(T4) & Triiodothyronine (T3). These hormones play a critical role in cell differentiation during development
and help maintain thermogenic and metabolic mechanism.
Thyroid hormone regulates the metabolism and affects nearly every organ in the body. Without enough
thyroid hormone, many of the body’s functions slow down. It is based on belief, that health and wellness
depend on a delicate balance between the mind, body and spirit. In the changing lifestyle of 21stcentury
hypothyroidism is considered as one of the commonest diseases.
Hypothyroidism is the major endocrine disorder seen in general population. It is characterized by the
deficiency of thyroid hormones to abnormal levels. This condition leads to the reduction in Basal metabolic
rate, affects physical and mental growth during infancy or childhood. The dysfunctioning of the ’Agni’ is
the basic cause of the clinical manifestations of Hypothyroidism. The hypofunctioning of jatharagni’ in
turn affects "Dhatwagni" which acts as the basic factor for the occurrence of the diseased condition
In Ashtanga Hridaya, Vagbhata emphasizes the importance of Kayagni and its direct implication on the
status and maintenance of the Dhatwagni, the Vriddhi/Kshina Avastha of the Jatharagni would result in the
same status of Dhatvagni too.
Kayagni present in its own place, has portions of itself, pre- sent in the Dhatus also. Their decrease
(in quantity, qualities or functions) and in- crease (in quantity, qualities or functions) give rise to increase and decrease of the Dhatus (respectively). If preceeding Dhatu is increased or decreased, it will
increase or decrease the succeeding Dhatu too.
Ayurveda is named as the science of life. It is one of the world’s oldest holistic healing system. In
Ayurvedic classics hypothyroidic problems are not described under a particular disease. On the basis of
Ayurvedic principles, we can understand the pathology of Hypothyroidism as that “Roga Sarveapi
Mandagnoâ€. In modern terminology “Agnimandya†can be understood as decreased caloric expenditure
which is present at systemic and cellular level. It is basically caused due to dysfunctioning of the Agni. It is
a metabolic disorder in which Agni (Jatharagani, Bhutagni, Dhatwagni) are at very low level.
Vriddhi of Vata Dosha and Kapha Dosha and Kshaya of Pitta is most important in genesis of disease
Hypothyrodism.Many of Rasa Pradoshaja Vikaras which have been mentioned in Charak Samhitaare
similar to the clinical features of Hypothyroidism i.e. Ashraddha, Aruchi, Gaurava, Tandra, Angamarda,
Panduroga, Klaibya, Srotorodha, Agnimandya etc.
METHOD OF PREPARATION OF TRIAL DRUG
Drug A: Sinduthaadi modaka – All the ingredients are taken in equal quantity and a fine powder is prepared
and jaggery is added equal to all 4parts drugs taken and modaka is prepared.
Drug B: Katutumbi taila – All the ingredients are taken in equal amount and a fine paste is prepared. Before
preparation of medicated taila the crude Taila should have processed with a special procedure. Tailais heated
till it becomes free from froth. 4 part of water is added along with 1 part of paste. It is boiled on moderate
heat till oil becomes free from water then oil is filtered. When all the darva dravayas have evaporated the
moisture in kalka will also begin to evaporate at this stage. It has to be stirred more oftenand carefully to
ensure paste does not stick. |