1.3. Need of the Study:

Despite the availability of various treatment modalities, including conventional pharmaceuticals, the management of Hypothyroidism remains challenging, often characterized by incomplete symptom relief and disease recurrence. In this context, there is a compelling need for novel acupuncture interventions that not only address the symptoms but also target the underlying imbalances contributing to the pathogenesis of the condition.

In India estimated that about 42 million people have thyroid disorders in India . Hypothyroidism, specifically, is the most common of thyroid disorders in India, affecting one in ten adults. The prevalence of hypothyroidism in India is 11% , compared with only 2% in the UK and 4·6% in the USA. Compared with coastal cities (eg, Mumbai, Goa, and Chennai), cities located inland (eg, Kolkata, Delhi, Ahmedabad, Bangalore, and Hyderabad) have a higher prevalence(11·7% vs 9·5%). The highest prevalence of Hypothyroidism (13.1%) is noted in people aged 46-54 years, with people aged 18-35 years being less affected (7.5%). Women are 6 times more prone than men. Hypothyroidism causes many symptoms related to low thyroid hormone levels, including feeling tired, feeling cold, dry skin and weight gain. Treating hypothyroidism by replacing thyroxine, the main hormone produced by the thyroid gland, resolves the symptoms of hypothyroidism in the majority of patients. However, many patients with a diagnosis of hypothyroidism report a decreased quality of life compared to people without hypothyroidism.

1.4. Research Gap Analysis

There is no previous research found about the effect of Acupuncture on serum TSH on hypothyroidism in stomach channel and liver channel.^[8-9]

1.5. Rational for selection of interventions/ justification for selection of trial acupuncture

The need for research in this area is multifaceted:

Ø  In modern time oral medicines in tablet form are the initial choice for most patients for every disease. They should be continued for longer time for normalizing hormone levels however it’s not tolerated by some patients.

Ø  Modern medical treatments in artificial hormone tablets may help to relieve symptoms of hypothyroidism but they do not address the root cause of the problem. With continuation of these treatment for long time some side-effect are still.

Ø  Also Increased demand in Traditional medicine treatment, as Acupuncture has become the safe place due to its non or negligible side effect, cost effectiveness.

2. RESEARCH QUESTION           

•        Is there any effect of Acupuncture on serum TSH in the patients of hypothyroidism?

3. HYPOTHESIS:

3.1. Null Hypothesis [Ho]-

•       There is no effect of Acupuncture on serum TSH levels in Hypothyroidism.

3.2. Alternative Hypothesis [HA]

•       There is an effect of Acupuncture on serum TSH levels in Hypothyroidism.            

 4. AIM

•       The aim of this study is to evaluate the efficacy of Acupuncture on serum TSH in the patients of Hypothyroidism with a single arm study.

5. OBJECTIVE

5.1. Primary objective:

To evaluate the efficacy of Acupuncture on serum TSH level in hypothyroidism.

5.2. Secondary objective

·       To study the efficacy of acupuncture on serum T3 and T4 levels.

·       To study the changes in sign and symptoms after taking session of Acupuncture in patients of Hypothyroidism.

6. MATERIALS AND METHODS:

6.1. Study Design:  Prospective single group interventional pre and post-test research design

6.1.1. Study type: Interventional

6.1.2. Phase of clinical trial: Phase II

6.1.3. Number of groups: one, 30 participants

6.2 & 6.3. Site of study & Study setting: The patients will be registered from OPD & IPD of National Institute of Ayurveda and associated hospitals.

6.4. Study duration: 18 months

6.5. Ethical aspects: It will be obtained after the review from the institutional ethical committee of National Institute of Ayurveda, Jaipur and trial will be started after CTRI registration.

6.6. Participants/ population of Interest: patients diagnosed with hypothyroidism

6.6.1. Sampling method: Convenience sampling

6.6.2. Sample size: 30

On the basis of primary outcome (TSH level) using effect size 0.7 (anticipated value with expert opinion), at 5% level of significance. 80% power and using dropout rate30%, the estimated sample size is 30. Calculation was done by GPOWER software.

6.6.3. SCREENING CRITERIA: Patients attending outdoor and indoor of National Institute of Ayurveda, Hospital, Jaipur and outdoor patient of satellite hospital Jaipur will be screened and eligible participants have to meet all the inclusion criteria.

6.6.4. DIAGNOSTIC CRITERIA:

•       Will be based as per standard guidelines.

                         Name of Marker              :Normal Range

1.     TSH                      : 0.4 – 5.0 mlU/L

2. Total T4                : 5.4-11.4 mcg/dL
3. Total T3                : 80-220 ng/dL

6.6.5 INCLUSION CRITERIA

•       Willingness to participate in the study and provide informed consent.

•       Male and female patients between the ages of 20–60 years.

•       Patients with hypothyroidism with TSH levels ranging from 5 mlU/L- 25 mlU/L

6.6.6 EXCLUSION CRITERIA

•       Pregnant or lactating women

•       Grade 2 and grade 3 Hypertension according to European society of hypertension guidelines 2023.

•       Presence of any other serious medical condition that may interfere with study participation

•       Patients doing substance abuse like alcohol etc.

•       Patients having significant depression and other medical serious systemic diseases like cancer, tuberculosis etc

•       diagnosed case of Polycystic Ovarian Disease (PCOD).

6.6.7 Allocation concealment: NA

6.6.8 Blinding/ Masking: NA

6.6.9 Withdrawal Criteria:

1.     Any major illness requiring any intervention.

2.     Compliance less than 80 percent.

3.     Person does not want to continue trial.

6.6.10 REFERRAL CRITERIA

•       If patients develop any severe illness during trial which needs management from higher center.

Standard Operating Procedure (SOP) for Acupuncture

Title:
SOP for Administration of Acupuncture in the Study on Hypothyroidism

Objective:
To standardize the process of acupuncture therapy in the study titled “A Single Arm Study to Evaluate the Effect of Acupuncture on Serum TSH Level in Hypothyroidism.”

Scope:
This SOP applies to all researcher performing acupuncture interventions as part of this study at the National Institute of Ayurveda.

Responsibilities:
- The Principal Investigator (PI) is responsible for ensuring SOP adherence.
- The acupuncturist will perform the procedures as per the defined protocol.
- Researcher will monitor and document each session.

Materials Required:
- Sterile acupuncture needles (0.25x25 mm)
- Alcohol swabs
- Cotton balls and antiseptic solution
- Disposable gloves
- Clinical recording sheets
- Clock or timer

Procedure:

1. Pre-session Preparation:
- Ensure a clean, quiet, temperature-controlled room (~25°C).
- Wash and sanitize hands. Wear gloves.
- Verify participant ID and informed consent.
- Record vitals and symptoms.
- Clean acupuncture sites with antiseptic.

2. Points of Administration:
- Stomach Channel: ST-8 (Touwei), ST-9 (Renying), ST-10 (Shuitu), ST-11 (Qishe), ST-12 (Quepen)
- Liver Channel: LIV-1 (Dadun), LIV-2 (Xingjian), LIV-3 (Taichong), LIV-4 (Zhongfeng), LIV-8 (Ququan)
- Ashi points: Identified at the anterior and posterior neck borders

3. Needle Insertion:

      - Insert the needle perpendicularly or obliquely depending on the location.
       - Depth: As per standard TCM practice (not more than 0.5–1.5 cun).
       - Retain needles for 35–40 minutes.
       - Monitor for discomfort or adverse reactions.

 4. Post-session:

      - Remove needles and discard in biohazard bin.
      - Apply gentle pressure with antiseptic cotton if needed.
      - Observe patient for 5–10 minutes.
      - Record session notes including time, response, and any complaints.

 5. Frequency:

      - 7 sittings per month, alternate-day schedule.
      - Total duration: 2 months.

6. Documentation:

     - Record each session’s date, duration, and patient feedback.
     - Document TSH, T3, T4 levels as per investigation schedule.

7. Intervention:

7.1 Details of Trial

Acupuncture channel: This network of channel connect the internal organs and the exterior of man, the microcosm, with the universe, the microcosm, to establish universal harmony. ^[10-11]

Mode of administration: on stomach channels and liver channels

Duration of treatment: 2 months

7.2 Method of Preparation

•       Sterile acupuncture needles with dimensions of 0.25x25 mm were used in the acupuncture treatments. Therapies are performed in a closed room at a temperature of about 25 degrees, for a duration of 35-40 minutes on both sides of the body. Specific acupuncture points for hypothyroidism are used in the treatment: St.8: Touwei, St.9: Renying, St.10: Shuitu, St.11: Qishe, St.12: Quepen Liv.1 –Dadun, Liv.2- Xingjian, Liv.3-Taichong, Liv.4-Zhongfeng, Liv.8-Ququan. Specific Ashi ie. trigger points are located at anterior and posterior borders of the neck. ^[12-15]

•       Total seven sittings will be given on alternate days per month.

8. Grouping: Single Group having 30 patients

9. Duration of Clinical Trial and follow-up study

9.1 Total Duration of Trial:  18 months

9.2  follow up during treatment: will be done in every 30 days

10.CONCOMITANT TREATMENT:   

•       Participants will be advised to continue their concomitant medications prescribed by their healthcare provider, throughout the study period.

11.RESCUE MEDICATIONS:

•       In the event of other complications necessitating additional treatment beyond the study interventions, participants may receive rescue medications as deemed necessary by the investigator

12. INVESTIGATION

13. ASSESSMENT CRITERIA

All the patients registered for the trial will be assessed on the basis of following parameters.

 Safety Assessment (under Secondary Endpoint)

•       Safety will be monitored through adverse event reporting and vital signs.

•       Local and systemic reactions to acupuncture will be documented.

Any adverse events will be reported to the IEC and Pharmacovigilance Cell.

14.1. PRIMARY OUTCOME:

The primary outcome of the study will be the change in TSH levels from baseline to the end of the treatment period.

14.2. SECONDARY OUTCOME:

·       Changes in the serum T3 and T4 levels.

·       Changes in the intensity of the symptoms associated with hypothyroidism comparative effect of Acupuncture.

14.3. PRIMARY ENDPOINT:

             Change in serum TSH levels from baseline to 30 and 60 days.

14.4. SECONDARY ENDPOINT:

             Evaluation of its impact on serum T3 and T4 levels, as well as changes in clinical symptoms. Any adverse events will be monitored and documented throughout the study period.

15. Statistical Analysis:

15.1 Appropriate statistical Paired ‘t’Test will be used.

15.2 Statistical software: Graph pad/SSPS

15.3 Level of Significance: p value < .005

16. DECLARATION: Enrolment of the patients for clinical trial will be started only after approval of ethics committee and registration of clinical trial in CTRI (Clinical Trial Registry of India). Any adverse drugs events/ reaction observed throughout the study period will be reported to Pharmacovigilance cell of National Institute of Ayurveda, deemed to be University (De-novo), Jaipur.