Use of Kanchanar Triphaladi Yog along with Thyroxine in Hypothyroidism

Not yet recruiting

Conditions: Hypothyroidism, unspecified. Ayurveda Condition: GALAGANDAH,

Registration Number: CTRI/2022/07/044382

Lead Sponsor: Dr Himani

Brief Summary: **TITLE OF DISSERTATION**

â€œRandomized 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**

â€¢ To evaluate the efficacy of Kanchnar Triphaladi Yog along with Thyroxine on Hypothyroidism in comparison with Thyroxine

â€¢ To review relevant literature on Hypothyroidism and Galganda in modern science and Ayurvedic perspective.

â€¢ To study possible mode of action of Kanchanar Triphaladi Yog in the management of Galganda w.s.r. to Hypothyroidism.

â€¢ To study the efficacy of Thyroxine in the management of Hypothyroidism

â€¢ 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 â€“ Kanchnar Triphaladi Yog along with Thyroxine is not significantally effective than Thyroxine in the management of Galganda w.s.r to Hypothyroidism

H1 â€“ 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.

1. Marked improvement TSH level within normal range

2. Moderate improvement Decrease in TSH >2-5micro IU/ml

3. Mild improvement Decrease in TSH<2 micro IU/ml

4. No improvement No change in TSH

**Subjective Criteria--**

| | | | | | |

| --- | --- | --- | --- | --- | --- |

| S.r.NO. Symptoms Grade0 Grade1 Grade2 Grade3

| 1 Weight gain/month Noless 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 Doesnâ€™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)

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method

Trial Locations

Locations (1): DY Patil school of Ayurveda,
🇮🇳
Thane, MAHARASHTRA, India
DY Patil school of Ayurveda,
🇮🇳Thane, MAHARASHTRA, India
Dr Himani
Principal investigator
9459421398
hs2933322@gmail.com