| CTRI Number |
CTRI/2022/07/044382 [Registered on: 27/07/2022] Trial Registered Prospectively |
| Last Modified On: |
26/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of Kanchanar Triphaladi Yog along with Thyroxine in Hypothyroidism |
|
Scientific Title of Study
|
Randomized controlled parallel group add on clinical study to assess the efficacy of Kanchanar Triphaladi Yog along with Thyroxine in the management of Galganda with special reference to Hypothyroidism |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himani |
| Designation |
PG Scholar |
| Affiliation |
DY Patil School of Ayurveda |
| Address |
DY Patil School of Ayurveda, 3rd floor, Dept of Kayachikitsa, block no. 10, DY Patil Vidyanagar,, Sec 7 , Nerul - 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9459421398 |
| Fax |
|
| Email |
hs2933322@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Satpute |
| Designation |
Associate Professor |
| Affiliation |
DY Patil School of Ayurveda |
| Address |
DY Patil School of Ayurveda, 3rd floor, Dept of Kayachikitsa, block no. 10, DY Patil Vidyanagar,Sec 7,Nerul - 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9890486825 |
| Fax |
|
| Email |
kalpana.satpute@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Satpute |
| Designation |
Associate Professor |
| Affiliation |
DY Patil School of Ayurveda |
| Address |
DY Patil School of Ayurveda, 3rd floor, Dept of Kayachikitsa, block no. 10, DY Patil Vidyanagar,Sec 7,Nerul - 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9890486825 |
| Fax |
|
| Email |
kalpana.satpute@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| DY Patil School of Ayurveda and hospital,DY Patil vidyanagar,sec7,Nerul,400706 |
|
|
Primary Sponsor
|
| Name |
Dr Himani |
| Address |
DY Patil School of Ayurveda, 3rd floor, Dept of Kayachikitsa, block no. 10, DY Patil Vidyanagar,, Sec 7 , Nerul - 400706
|
| Type of Sponsor |
Private medical college |
|
|
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 Himani |
DY Patil school of Ayurveda, |
DY Patil School of Ayurveda, 3rd floor, Dept of Kayachikitsa, block no. 10, DY Patil Vidyanagar,, Sec 7 , Nerul - 400706.
Thane
MAHARASHTRA |
9459421398
hs2933322@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
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: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab throxine | DOSE- 0.05-0.2 milligram/kg body weight OD(bbf | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kanchanar Triphaladi Yog, Reference: Gadh nigrah 4/35, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient already diagnosed as Primary Hypothyroidism and under Thyroxine medication with serum TSH level >5micro IU/ml to <30micro IU/ml.
2.Patinet who are ready to take Ayurvedic Medicine and sign informed consent form |
|
| ExclusionCriteria |
| Details |
1.Patient suffering from systemic disease like cardiac disorders,Diabetes Mellitus ,COPD,TB,HIV,HCV,HBsAg
2.Immuno-compromised patients.
3.Pregnancy and lactating mother and renal insufficiency
4.Patient who are known case of congenital Hypothyroidism,secondary Hypothyroidism,Thyroid,Neoplasia and progressive cases of Myxedema coma.
5.Any serious medical and psychological condition will be excluded |
|
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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 |
| Improvement in Tsh level to normal limit and relief in symptoms like Weight gain,Constipation,Dyspnoea,Hair losss,Oedema,Mennorrhagia |
Day1,Day30,Day60,Day90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/07/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE OF DISSERTATION “Randomized Controlled Parallel Group Add on Clinical study to assess the efficacy of Kanchanar Triphaladi Yog along with Thyroxine in the management of Galganda with special reference to Hypothyroidismâ€
AIM To assess the efficacy of Kanchanar Triphaladi Yog along with Thyroxine in the management of Galganda with special reference to Hypothyroidism
OBJECTIVES • To evaluate the efficacy of Kanchnar Triphaladi Yog along with Thyroxine on Hypothyroidism in comparison with Thyroxine • To review relevant literature on Hypothyroidism and Galganda in modern science and Ayurvedic perspective. • To study possible mode of action of Kanchanar Triphaladi Yog in the management of Galganda w.s.r. to Hypothyroidism. • To study the efficacy of Thyroxine in the management of Hypothyroidism • To study the efficacy of Kanchanar Triphaladi Yog along with Thyroxine in previously diagnosed cases of Primary Hypothyroidism
RESEARCH QUESTION Is Kanchanar Triphaladi Yog along with Thyroxine effective in the management of Galganda w.s.r. to Hypothyroidism ?
HYPOTHESIS PRIMARY HYPOTHESIS H0 – Kanchnar Triphaladi Yog along with Thyroxine is not significantally effective than Thyroxine in the management of Galganda w.s.r to Hypothyroidism H1 – Kanchnar Triphaladi Yog along with Thyroxine is significantally effective than Thyroxine in the management of Galganda w.s.r to Hypothyroidism.
Diagnostic Criteria: Objective Criteria: Free T3/Free T4/TSH will be done in the initiation of the study and at the completion of the study. - Marked improvement TSH level within normal range
- Moderate improvement Decrease in TSH >2-5micro IU/ml
- Mild improvement Decrease in TSH<2 micro IU/ml
- No improvement No change in TSH
Subjective Criteria--| S.r.NO. | Symptoms | Grade0 | Grade1 | Grade2 | Grade3 | | 1 | Weight gain/month | No | less than 2kg | 2-5 kg | >5kg | | 2 | Mennorrhagia followed by Amenorrhea | No | 1 And1/2 months | 2-3months | >3months | | 3 | Hoarsness of voice | No | Occasional Present | Present but no difficulty in talking | Present with difficulty in talking | | 4 | Loss of appetite | Normal | Instinct for food taking | Seek for food taking but refuses taking | Doesn’t seek for food taking | | 5 | Constipation | No | Relieves after natural remedies | Not relieved after natural remedies | Not relieved even after Laxative | | 6 | Somnolence(Duration of sleep) | 6 to 7hrs/day | 8 to 9hrs/day | 10hrs/day | More then10hrs/day | | 7 | Dyspnoea | No | Breathlessness on severe exertion | Breathlessness on mild exertion | Breathlessness at rest | | 8 | Oedema | No Oedema | Oedema on lower/Upper extremity | Oedema on both upper and lower extremities | Oedema on all over the body | | 9 | Dryness of skin | No dryness | Faint line on scrubbing with nail | Dryness leads to crack formation | Dryness leads to crack formation with bleeding | | 10 | Hair Loss Not Significant Only after washing Significant hair loss on combing Throughout the day | Not Significant | Only after washing | Significant hair loss on combing | Throughout the day |
METHOD OF COLLECTION OF DATA 1. A proforma will be prepared with details of history,physical examination,pathological investigation. 2.The general condition of the patient,severitiy of symptoms before starting the treatment will be recorded properly.the presenting symptoms will be observed on Day 0th, Day 30th, Day 60th ,Day 90th
SOP of Preparation of Kanchanar Triphaladi Yog
Kanchanar Triphaladi Kashaya will be prepared as per the reference in the Sharangdhar Samhita Adhaya 2,Shloka No.1 & 2. Here Acharya have advised to take ingredients in Bharada or Churna 1 part of herbs in 16parts of water, which is reduced to 1/8th part of liquid after simmering or cooking on a low flame. Similarly, we will be taking 5gms of each ingredient (i.e 10gms of Churna) & 16 parts of water (160 ml)which will be reduced to 1/8th part of liquid after simmering or cooking on a low flame,afterwards prakshep dravya(pippali 0.5gm) will be added,hence Kanchanar Triphaladi Kashaya of 20 ml will be formed.
DOSE-20 ml BD Kaal-Vyanodan kaal
Tab Thyroxine Tab Thyroxine will be collected from Pharmacy
DOSE- 0.05-0.2 milligram/kg body weight OD(bbf)
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