| CTRI Number |
CTRI/2024/05/066849 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of hypothyrodism with purgation therapy and three types of enema |
|
Scientific Title of Study
|
A randomised controlled clinical study to evaluate the efficacy of virechana karma and sushrutokta trividha basti with varunadi kashaya in the management of hypothyrodism |
| 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 Dipender Kumar Sharma |
| Designation |
PG Scholar |
| Affiliation |
Parul Ayurved Hospital |
| Address |
Panchakarma OPD no 105 and IPD Parul Ayurved Hospital Parul
University Limda Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8233637764 |
| Fax |
02668-260201 |
| Email |
dipusharma3545@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nirmala Sonawane |
| Designation |
Professor |
| Affiliation |
Parul Ayurved Hospital |
| Address |
Room No 303 Department of Panchakarma Parul Institute of
Ayurveda Parul University Limda Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8329614671 |
| Fax |
02668-260201 |
| Email |
ayurved05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nirmala Sonawane |
| Designation |
Professor |
| Affiliation |
Parul Ayurved Hospital |
| Address |
Room No 303 Department of Panchakarma Parul Institute of
Ayurveda Parul University Limda Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8329614671 |
| Fax |
02668-260201 |
| Email |
ayurved05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panchakarma - OPD no 105 and IPD, Parul Ayurved Hospital, Parul University, Limda,
Vadodara, Gujarat, Pin no - 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Ayurved Hospital |
| Address |
Panchakarma - OPD no 105 and IPD, Parul Ayurved Hospital, Parul
University, Limda, Vadodara, Gujarat, Pin no - 391760 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Dipender Kumar Sharma |
Parul Ayurved Hospital |
Panchakarma - OPD no. 105, Parul Ayurved Hospital, Parul University, Vadodara.
Vadodara
GUJARAT |
8233637764
dipusharma3545@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
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:E039||Hypothyroidism, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Sushrutokta Trividh Basti (Utkleshana Basti, Doshhara Basti, Shamana Basti) | (Procedure Reference: Sushruta Samhita Chikitsasthana- (38-93/94/95), Procedure details: Utkleshana Basti (Anuvasana Basti-240 ml)
Doshhara Basti (Niruh Basti-1164 ml)
Shamana Basti (Ksheer Basti-552 ml))
(1) Medicine Name: Utkleshana Basti (Anuvasana Basti-240 ml) , Reference: Sushruta Samhita Chikitsasthana-(38-93), Route: Rectal, Dosage Form: Taila, Dose: 240(ml), Frequency: od, Duration: 4 Days(2) Medicine Name: Doshhara Basti (Niruh Basti-1164 ml), Reference: Sushruta Samhita Chikitsasthana-(38-94), Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 1164(ml), Frequency: od, Duration: 4 Days(3) Medicine Name: Shamana basti (Ksheer Basti-552 ml), Reference: Sushruta Samhita Chikitsasthana-(38-95), Route: Rectal, Dosage Form: Ksheerpaka, Dose: 552(ml), Frequency: od, Duration: 4 Days | | 2 | Comparator Arm | Procedure | - | Virechan Karma | (Procedure Reference: Astanga Hrdaya of Vagbhata, Kalpasidhisthanam, Ch. 2, Ver. 9., Procedure details: Deepana-Pachana-3 to 4 days
Snehpana-5 to 7 days (Till Samyak Snigdha
Lakshna Achieved)
Vishram Kala-3 days
Virechana Karma- 1 day
Samsarjan Karma - (As per Suddhi)
)
(1) Medicine Name: Trivrit Lehyam, Reference: Astanga Hrdaya of Vagbhata, Kalpasidhisthanam, Ch. 2, Ver. 9., Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 30(g), Frequency: od, Duration: 1 Days | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Varunadi Kashaya, Reference: Astanga Hrdaya of Vagbhata, Suthra Sthana, Ch. 15, Ver. 21-22. , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Sujects belonging to age group of 18 to 50 years of all gender were included.
2.Subjects with the TSH value value greater then 5.5 mIU/L to less then 25 mIU/L.
3.Subjects with elevated level of TSH which may or may not be associated with the reduced value of T3 and T4.
4.Both fresh and treated cases of hypothyrodism will be included.
A.Freshly detected and untreated cases of hypothyrodism.
b.Established and treated cases of hypothyrodism. |
|
| ExclusionCriteria |
| Details |
1.Subjects with congenital hypothyrodism, chronic history of hypothyrodism (greater then 5 yeatrs) and secondary hypothyrodism.
2.Subjects with any systemic illnesses which interrupt the present intervention.
3.Subjects who had undergone thyroid surgery.
4.Pregnant and lactating women.
5.Diagnosed cases of neoplastic conditions,toxic goitre. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptoms
1.Diminished sweating
2.Hoarseness
3.Dry skin
4.Consipation
5.Weight increase
6.Paraesthesia
7.Impairment of hearing
Physical Signs
1.Coarse skin
2.Cold skin
3.Periorbital puffiness
4.Slow movements
5.Delayed ankle reflex |
12 days of treatment
After 12 days of treatment follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
There will be increased quality of life in hypothyrodism
patients and complications of the disease will be
reduced. |
17 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/06/2024 |
| 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="1"
Months="6"
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 - NO
|
|
Brief Summary
|
Hypothyroidism is one among the endocrinal disorder. Thyroid is an endocrinal gland secrets T3 and T4 hormones regulated by TSH which is secreted by Pituitary gland. The prevalence of hypothyroidism in India is 11%. To date, no proper curative measures are found to treat hypothyrodism in modern science, so it is necessary to find a safe and effective measure for hypothyrodism.Hypothyroidism is a autoimmune disorder which is correlated with dhatu agni mandya and lena dosha avastha. In this study Sushrutokta Trivdh Basti can help in utkleshan of lean dosha there after their sodhan and shaman. So an attempt is made to study the efficacy of Shushrutokta Trivdh Basti in this condition. Virechana is the best therapy for the Pitta, Pitta associated with Kapha or Vata, and for Dosha situated in Pittasthana. Hypothyroidism refers to the underactivity of thyroid gland resulting into deficiency of thyroid hormones which may be considered as malfunctioning of Agni (Pitta). Virechana is the best treatment for the regulation of Pitta Dosha and agni. So an attempt is made to study the efficacy of Shushrutokta Trivdh Basti and Virechan Karma With Varunadi Kashaya in the management of Hypothyrodism.
RESEARCH QUESTION:
Is Virechana Karma and Sushrutokta trividha basti followed by Shamana (Varunadi Kashaya) effective in the management of Hypothyrodism?
AIM:
TO EVALUATE THE EFFICACY OF VIRECHANA AND SUSHRUTOKT TRIVIDHA BASTI AND VARUNADI KASHAYA IN THE MANAGEMENT OF HYPOTHYRODISM
OBJECTIVES: 1. To Study the effect of Virechan Karma in the management of Hypothyroidism 2. To Study the effect of Sushrutokt Trividha Basti and observe its effect in the management of Hypothyrodism 3. To Study the effect of Varunadi Kashaya in the management of Hypothyroidism
MATERIAL AND METHODS:
DURATION OF STUDY: 18 Months STUDY DESIGN: Randomised comparative clinical trial Purpose of the study will be explained and written informed consent will be taken from every patients. Source of data - LITERARY SOURCE: All the available literature regarding Virechan Karma and Sushrutokta trividha basti and varunadi kashay in classical and contemporary texts including journals and online sources will be reviewed and documented for the study.
- PHARMACEUTICAL SOURCE : Medicine will be prepared in the GMP Certified pharmacy.
- CLINICAL SOURCE : Diagnosed cases of Hypothyroidism, will be selected from OPD and IPD of Parul Ayurved Hospital, Limda, Vadodara, Parul Sevashram Hospital, Vadodara and special campaigns fulfilling the criteria of selection and who are willing to participate in the present study will be included for the clinical study.
TREATMENT GROUPS:
GROUP A (Trial Group) - 20 Patients will be administered Sushrutokta Trividha Basti by Shamana (Varunadi Kashaya).
GROUP B (Control Group) - 20 Patients will be administered Virechana Karma followed by Shamana (Varunadi Kashaya).
SUBJECTIVE CRITERIA:
Symptoms:
Tiredness,Weakness Dry Skin Feeling colds Hair Loss Difficulty in concentrating and poor memory Constipation Weight gain with poor appetite Hoarse voice Menorrhagia Paraesthesia Dyspnoea Impaired hearing
Signs: Dry Coarse Skin Cool peripheral extremities Puffy face Diffused alopecia Bradycardia Peripheral Oedema Delayed tendon reflex Carpel tunnel syndrome
OBJECTIVE CRITERIA:
T3 T4 TSH
INTERVENTION: Sushrutokta Trividh Basti (in Chaturbhadra Kalpa Basti pattern): Chaturbhadra Kalpa Basti: 12 days
| 1st day | 2nd day | 3rd day | 4th day | 5th day | 6th day | 7th day | 8th day | 9th day | 10th day | 11th day | 12th day | | AB | AB | AB | AB | NB | NB | NB | NB | KB | KB | KB | KB |
Here, AB - Anuvasana Basti NB - Niruha Basti KB - Ksheer Basti
Basti Quantity - Anuvasan Basti - 240 ml
- Niruh Basti - 1164 ml
- Ksheer Basti - 582 ml
Follow up - Before Treatment (Day- 1) After Treatment (Day-13) After One Month (Day-30)
The effect of the Basti (Panchakarma therapy) will be assessed based on the following criteria –
Samyak Basti Lakshanas The retention time of Basti Number of purisha vega Possible complications after administration of Basti Vital data of patients
Intervention Of Virechan Karma:
| Deepana-Pachana | Snehpana | Vishram Kala | Virechana Karma | Samsarjan Karma | Aampachak Vati
Chitrakadi Vati | Moorchita Tila Taila | Abhyanga and Swedana | Trivrit Lehyam | Peya, Vilepi, Akritkrityush, Akritkritmamshrash | | 3 to 4 days | 5 to 7 days (Till Samyak Snigdha Lakshna Achieved) | 3 days | After 3 days of Vishram Kala | As Per Suddhi |
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