Development

From the past to the present, the development story of HT042

Development

Until the medicinal herbs in Donguibogam become the No.1 raw material for children’s height growth certified the first and only in Korea by the Ministry of Food and Drug Safety

The reason why the HT042 research team started to study height growth in 1999 was because we thought there was no reliable height growth product at the time.
After persistent research, we established our own method and finally developed the HT042.
Under this belief, we are developing better products.

Follow the exciting journey to learn more about the bone-chilling R&D story of the HT042 research team.

Can we measure height grown up directly?

The study of height growth in children began in 1999.
Beyond simple nutritional supplementation, is it possible to gain additional height?
We looked for products and studies that had been released until then, but there was no proper height growth material or research anywhere.
So we decided to do a height growth experiment ourselves, and tried to measure the height grown up in real time.

Why is it important to measure height grown up in real time?
Just as people have different heights, mice also have different lengths.
This is because it is most accurate to measure the growth length in real time during the same time period during which the test substance is administered.

So we developed the first real-time height growth measurement method.

The first method for measuring height growth, tetracycline calcium fluorescence labeling method

After numerous trials and errors, we developed an experimental animal model.
When tetracyclineis injected into a rat, calcium is deposited in areas where cartilage cells become bone, and fluorescent lines appear.
The distance between the end of the growth plate and the fluorescent line observed 24 hours after injection was the length of bone grown in 24 hours.

Using this method, we injected growth hormone and administered herbal medicines that were said to be effective to rats for experiment.

The results obtained by this method were published in the European Journal of Pediatrics in 2002.

Compare the difference of 1/10th the thickness of a hair

When the effective substance is administered, the length of the bone grown in rats per day increases by 10-20 μm.
This is a subtle difference that is only 1/5 - 1/10 the thickness of a human hair.
You must clearly observe this difference to find an effective substance.

By the way, the comparison group in the height growth study is a group that grows normally.
Compared to the normal group, the difference is much smaller.
Just as each person's growth rate is different,the naturally occurring individual differences in the growth rate of rats also made the research difficult.

The height growth research team constantly repeated experiments to reduce errors.

Finding HT042 through repeated, repeated, and endless experiments

Through iMED, a natural material development platform, we began to measure the effectiveness of herbal medicines that are said to be effective in children's growth.

Growth hormone was used as a control group, but we tried to find herbal medicines with similar effects to growth hormone.
Each herbal medicines was administered individually and the effect was observed.
In the meantime, it was found that Astragalus, Acanthopanax senticosus, and Phlomis umbrosa each accelerated the height growth rate.
By blending these in an optimal ratio, a highly effective complex was developed.

This is the HT042.

The world's first double-blind clinical trial of height growth with natural product

A 12-week randomized double-blind clinical trial was conducted on short children aged 7-12 years.

As a result of the experiment, the children who consumed HT042(experimental group) showed a statistically significant additional growth effect(about 17%) compared to the children who consumed a placebo similar in taste and appearance to HT042 but containing no ingredients(control group).
There were no precocious puberty or special side effects.

Until then, there was no successful case in the world in a double-blind test of height growth with natural products.

The double-blind method is a method of conducting an experiment without knowing whether the subjects are taking the real medicine or the fake medicine. This is called a double-blind method because even the doctor who is doing the observation is unaware. It's called the Double Blind Test in English because of seeing nothing.
This is the highest level of evidence usually used in medicine development.

Acquiring each functional ingredient certification for the first time in Korea

We submitted data such as safety, functional standards and specifications of HT042 that we have studied so far to the Ministry of Food and Drug Safety,
and through evaluation in accordance with relevant regulations, the functionality of can help children grow taller was certified for the first time in Korea.

As of 2024, it is the only height growth functional ingredient.
Products that do not contain HT042 cannot claim to help children grow taller.

Second clinical trial in younger children

Because children have different height growth rates, 140 children aged 6-8 years who are in the lower 25% of short heights were recruited and conducted a 24-week, multicenter, randomized, double-blind, human application test.
In addition, indicators related bone age and sex hormone were newly set to evaluate not only the growth rate but also whether the growth period was shortened or not.

As a result of measuring height at 24 weeks, children who took HT042 again showed a statistically significant additional growth effect compared to the control group who took placebo.
In particular, the effect of HT042 was more pronounced in children in the bottom 10% or less. Children who took HT042 accelerated growth compared to the control group, but did not increase bone age or increase sex hormone levels.

This result means that intake of HT042 helps the child grow faster while maintaining the growth period, rather than bring the height which is grown up in future anyway ahead of time.
This study is the first randomized clinical trial of height growth with natural product published in an SCI-level journal.

Non-stop research for height growth

Research into the effectiveness and safety of HT042 is ongoing.
10 international academic journal papers related to HT042 have been published on functionality such as growth rate promotion, mechanism of action, toxicity, and safety such as precocious puberty. HT042 is one of the ingredients for which the most papers have been published among the each functional ingredient category developed in Korea.

In addition to HT042, we have been researching various natural products that help growth for over 20 years.
To date, in addition to HT042, 12 domestic and international papers have been published.
The HT042 research team is the group that has published the most many papers in the world on the growth-promoting effects of natural products.

Based on the above results, 10 domestic and foreign patents were registered, and the first prize was awarded by the Medicinal Goods Committee of the World Federation of Chinese Medicine Societies (WFCMS), the largest traditional medicine society.

From a health functional food to a new medicine: Acquisition of an IND for a treatment for short stature in children

We are not stopping here and are promoting the development of medicines that can treat patients with short stature.
The goal is to develop a treatment for patients with idiopathic short stature, whose height is below the bottom 3%, without any specific cause.

As a result of the research supported by the Ministry of Health and Welfare, we succeeded in the approval of the first natural product clinical trial plan(IND phase 2b) for idiopathic short stature treatment.

We are concentrating on research today to develop a treatment for idiopathic short stature, which accounts for the majority of short stature.